Trial Outcomes & Findings for A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects (NCT NCT00296504)
NCT ID: NCT00296504
Last Updated: 2013-04-19
Results Overview
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
753 participants
Primary outcome timeframe
Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Results posted on
2013-04-19
Participant Flow
APV30005 enabled Human Immunodeficiency Virus (HIV)-infected participants who had received a Fosamprenavir (FPV)-containing or other regimen in a number of studies, including APV30001, APV30002, and APV30003, to receive FPV until 31 January 2006 (Interim Analysis) or until commercial supplies of FPV were available locally, whichever was later.
Participants are divided into arms depending on the regimen they received in Studies APV30001, APV30002, and APV30003 or whether they were PI-naïve or PI-experienced at the time they enrolled into other studies. For the final analysis, 111 participants are included who continued in APV30005 after 31 January 2006 until study completion.
Participant milestones
| Measure |
FPV Population (APV30001)
Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001
|
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV Once Daily (QD) Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV/RTV Twice Daily (BID) Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
Protease Inhibitor (PI)-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
|
|---|---|---|---|---|---|---|---|---|---|
|
Interim Analysis
STARTED
|
119
|
18
|
221
|
54
|
73
|
78
|
104
|
86
|
0
|
|
Interim Analysis
Ongoing
|
32
|
12
|
16
|
22
|
0
|
0
|
30
|
1
|
0
|
|
Interim Analysis
COMPLETED
|
43
|
0
|
116
|
11
|
36
|
41
|
30
|
37
|
0
|
|
Interim Analysis
NOT COMPLETED
|
76
|
18
|
105
|
43
|
37
|
37
|
74
|
49
|
0
|
|
Final Analysis
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
111
|
|
Final Analysis
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
90
|
|
Final Analysis
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
21
|
Reasons for withdrawal
| Measure |
FPV Population (APV30001)
Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001
|
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV Once Daily (QD) Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV/RTV Twice Daily (BID) Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
Protease Inhibitor (PI)-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
|
|---|---|---|---|---|---|---|---|---|---|
|
Interim Analysis
Withdrawal by Subject
|
8
|
0
|
12
|
0
|
5
|
5
|
9
|
3
|
0
|
|
Interim Analysis
Lost to Follow-up
|
13
|
3
|
26
|
8
|
14
|
4
|
11
|
4
|
0
|
|
Interim Analysis
Clinical Progression
|
1
|
0
|
1
|
1
|
0
|
2
|
1
|
2
|
0
|
|
Interim Analysis
Insufficient Viral Load Response
|
5
|
1
|
12
|
2
|
7
|
9
|
2
|
24
|
0
|
|
Interim Analysis
Adverse Event
|
0
|
0
|
13
|
4
|
6
|
3
|
4
|
5
|
0
|
|
Interim Analysis
Protocol Violation
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Interim Analysis
Insufficient CD4 Response
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Interim Analysis
Switched to Commercially Available Drug
|
2
|
0
|
4
|
1
|
0
|
5
|
3
|
4
|
0
|
|
Interim Analysis
Pregnancy
|
4
|
1
|
4
|
2
|
0
|
1
|
1
|
1
|
0
|
|
Interim Analysis
Death
|
1
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Participant Non-compliant
|
0
|
1
|
2
|
1
|
1
|
3
|
6
|
2
|
0
|
|
Interim Analysis
Participant Wanted to Become Pregnant
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Interim Analysis
To Simplify Treatment
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Interim Analysis
Participant Had Problems with Alcohol
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Participant Moved
|
1
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Interim Analysis
Participant Was Incarcerated
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Resistance to FPV
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Principle Investigator Discretion
|
2
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Principle Investigator Terminated Study
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Non-adherence
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Interim Analysis
Site Closing
|
1
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Interim Analysis
Lack of Personnel at Site
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Missed Schedule Date
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Inclusion in Other Protocol
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Participant Stopped
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Interim Analysis
Physician and Participant Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Interim Analysis
Participant Stopped HIV Medications
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Interim Analysis
Study Ended
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Interim Analysis
Participant Needed Interferon
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Interim Analysis
Ongoing
|
32
|
12
|
16
|
22
|
0
|
0
|
30
|
1
|
0
|
|
Final Analysis
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Final Analysis
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Final Analysis
Insufficient Viral Load Response
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Final Analysis
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Final Analysis
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
|
Final Analysis
Tuberculosis
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Final Analysis
Participant Moved to Another Country
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Final Analysis
Poor Adherence
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
Baseline characteristics by cohort
| Measure |
FPV Population (APV30001)
n=119 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
NFV Population (APV30001)
n=18 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=221 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=54 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
n=73 Participants
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV/RTV BID Population (APV30003)
n=78 Participants
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
n=104 Participants
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
n=86 Participants
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
Total
n=753 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
|
36.3 years
n=99 Participants
|
35.8 years
n=107 Participants
|
37.7 years
n=206 Participants
|
36.2 years
n=7 Participants
|
41.9 years
n=31 Participants
|
42.3 years
n=30 Participants
|
39.3 years
n=3 Participants
|
40.2 years
n=6 Participants
|
38.7 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
198 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=31 Participants
|
66 Participants
n=30 Participants
|
80 Participants
n=3 Participants
|
64 Participants
n=6 Participants
|
555 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
34 participants
n=99 Participants
|
1 participants
n=107 Participants
|
109 participants
n=206 Participants
|
14 participants
n=7 Participants
|
59 participants
n=31 Participants
|
56 participants
n=30 Participants
|
44 participants
n=3 Participants
|
77 participants
n=6 Participants
|
394 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black
|
35 participants
n=99 Participants
|
6 participants
n=107 Participants
|
86 participants
n=206 Participants
|
34 participants
n=7 Participants
|
10 participants
n=31 Participants
|
14 participants
n=30 Participants
|
34 participants
n=3 Participants
|
7 participants
n=6 Participants
|
226 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
4 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
1 participants
n=30 Participants
|
1 participants
n=3 Participants
|
0 participants
n=6 Participants
|
8 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
American Hispanic
|
49 participants
n=99 Participants
|
11 participants
n=107 Participants
|
16 participants
n=206 Participants
|
2 participants
n=7 Participants
|
3 participants
n=31 Participants
|
7 participants
n=30 Participants
|
23 participants
n=3 Participants
|
2 participants
n=6 Participants
|
113 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other: Race Not Specified
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
6 participants
n=206 Participants
|
4 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
2 participants
n=3 Participants
|
0 participants
n=6 Participants
|
12 participants
n=114 Participants
|
|
Number of Participants with the Indicated CDC Classification of HIV Infection
Asymptomatic or lymphadenopathy
|
81 participants
n=99 Participants
|
16 participants
n=107 Participants
|
124 participants
n=206 Participants
|
13 participants
n=7 Participants
|
26 participants
n=31 Participants
|
30 participants
n=30 Participants
|
76 participants
n=3 Participants
|
29 participants
n=6 Participants
|
395 participants
n=114 Participants
|
|
Number of Participants with the Indicated CDC Classification of HIV Infection
Symptomatic, not AIDS
|
17 participants
n=99 Participants
|
1 participants
n=107 Participants
|
48 participants
n=206 Participants
|
23 participants
n=7 Participants
|
21 participants
n=31 Participants
|
24 participants
n=30 Participants
|
23 participants
n=3 Participants
|
18 participants
n=6 Participants
|
175 participants
n=114 Participants
|
|
Number of Participants with the Indicated CDC Classification of HIV Infection
Acquired Immune Deficiency Syndrome (AIDS)
|
21 participants
n=99 Participants
|
1 participants
n=107 Participants
|
49 participants
n=206 Participants
|
18 participants
n=7 Participants
|
26 participants
n=31 Participants
|
24 participants
n=30 Participants
|
5 participants
n=3 Participants
|
39 participants
n=6 Participants
|
183 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to 31 January 2006 (up to Week 264)Population: All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Outcome measures
| Measure |
NFV Population (APV30001)
n=18 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=221 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=54 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
n=73 Participants
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=119 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
n=78 Participants
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
n=104 Participants
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
n=86 Participants
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE): Interim Analysis
|
16 participants
|
215 participants
|
52 participants
|
72 participants
|
117 participants
|
75 participants
|
95 participants
|
68 participants
|
PRIMARY outcome
Timeframe: Post January 2006; for up to 241 weeksPopulation: All participants who remained in the study after January 31, 2006.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Outcome measures
| Measure |
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=111 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE): Final Analysis
|
—
|
—
|
—
|
—
|
95 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216Population: All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005. Only those participants contributing data at the indicated time points were analyzed.
Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Outcome measures
| Measure |
NFV Population (APV30001)
n=14 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=159 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=38 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
n=61 Participants
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=92 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
n=65 Participants
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
n=77 Participants
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
n=59 Participants
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
17 milligrams per deciliter (mg/dl)
Interval 7.0 to 25.0
|
4 milligrams per deciliter (mg/dl)
Interval 3.0 to 6.0
|
3 milligrams per deciliter (mg/dl)
Interval -5.0 to 4.0
|
16 milligrams per deciliter (mg/dl)
Interval 9.0 to 26.0
|
6 milligrams per deciliter (mg/dl)
Interval -3.0 to 12.0
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48
|
10 milligrams per deciliter (mg/dl)
Interval -11.0 to 16.0
|
30 milligrams per deciliter (mg/dl)
Interval 10.0 to 53.0
|
0 milligrams per deciliter (mg/dl)
Interval -8.0 to 19.0
|
2 milligrams per deciliter (mg/dl)
Interval -24.0 to 21.0
|
32 milligrams per deciliter (mg/dl)
Interval 20.0 to 53.0
|
-1 milligrams per deciliter (mg/dl)
Interval -15.0 to 24.0
|
3 milligrams per deciliter (mg/dl)
Interval -13.0 to 21.0
|
17 milligrams per deciliter (mg/dl)
Interval 10.0 to 29.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59
|
-41 milligrams per deciliter (mg/dl)
Interval -63.0 to -20.0
|
51 milligrams per deciliter (mg/dl)
Interval 14.0 to 118.0
|
20 milligrams per deciliter (mg/dl)
Interval -19.0 to 57.0
|
9 milligrams per deciliter (mg/dl)
Interval -25.0 to 44.0
|
10 milligrams per deciliter (mg/dl)
Interval -34.0 to 42.0
|
14 milligrams per deciliter (mg/dl)
Interval -69.0 to 66.0
|
5 milligrams per deciliter (mg/dl)
Interval -27.0 to 58.0
|
-54 milligrams per deciliter (mg/dl)
Interval -96.0 to -12.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44
|
-48 milligrams per deciliter (mg/dl)
Interval -101.0 to 8.0
|
47 milligrams per deciliter (mg/dl)
Interval 10.0 to 101.0
|
15 milligrams per deciliter (mg/dl)
Interval -22.0 to 48.0
|
16 milligrams per deciliter (mg/dl)
Interval -51.0 to 40.0
|
9 milligrams per deciliter (mg/dl)
Interval -26.0 to 43.0
|
34 milligrams per deciliter (mg/dl)
Interval -21.0 to 118.0
|
-5 milligrams per deciliter (mg/dl)
Interval -35.0 to 42.0
|
7 milligrams per deciliter (mg/dl)
Interval -3.0 to 41.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40
|
-33 milligrams per deciliter (mg/dl)
Interval -77.0 to 0.0
|
43 milligrams per deciliter (mg/dl)
Interval 2.0 to 121.0
|
-4 milligrams per deciliter (mg/dl)
Interval -24.0 to 69.0
|
13 milligrams per deciliter (mg/dl)
Interval -27.0 to 49.0
|
15 milligrams per deciliter (mg/dl)
Interval -24.0 to 59.0
|
22 milligrams per deciliter (mg/dl)
Interval -39.0 to 96.0
|
-4 milligrams per deciliter (mg/dl)
Interval -50.0 to 50.0
|
-73 milligrams per deciliter (mg/dl)
Interval -283.0 to 2.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40
|
-2 milligrams per deciliter (mg/dl)
Interval -66.0 to 6.0
|
47 milligrams per deciliter (mg/dl)
Interval 0.0 to 101.0
|
18 milligrams per deciliter (mg/dl)
Interval -21.0 to 58.0
|
14 milligrams per deciliter (mg/dl)
Interval -63.0 to 65.0
|
2 milligrams per deciliter (mg/dl)
Interval -27.0 to 46.0
|
18 milligrams per deciliter (mg/dl)
Interval -61.0 to 63.0
|
6 milligrams per deciliter (mg/dl)
Interval -48.0 to 32.0
|
-129 milligrams per deciliter (mg/dl)
Interval -343.0 to 75.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33
|
-12 milligrams per deciliter (mg/dl)
Interval -58.0 to 25.0
|
27 milligrams per deciliter (mg/dl)
Interval -19.0 to 86.0
|
4 milligrams per deciliter (mg/dl)
Interval -16.0 to 49.0
|
29 milligrams per deciliter (mg/dl)
Interval -55.0 to 59.0
|
3 milligrams per deciliter (mg/dl)
Interval -27.0 to 66.0
|
42 milligrams per deciliter (mg/dl)
Interval -25.0 to 177.0
|
5 milligrams per deciliter (mg/dl)
Interval -32.0 to 27.0
|
-167 milligrams per deciliter (mg/dl)
Interval -238.0 to -10.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40
|
-41 milligrams per deciliter (mg/dl)
Interval -89.0 to 7.0
|
37 milligrams per deciliter (mg/dl)
Interval 4.0 to 87.0
|
18 milligrams per deciliter (mg/dl)
Interval -16.0 to 81.0
|
13 milligrams per deciliter (mg/dl)
Interval -27.0 to 63.0
|
8 milligrams per deciliter (mg/dl)
Interval -38.0 to 43.0
|
8 milligrams per deciliter (mg/dl)
Interval -95.0 to 112.0
|
-2 milligrams per deciliter (mg/dl)
Interval -38.0 to 20.0
|
-170 milligrams per deciliter (mg/dl)
Interval -267.0 to -56.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40
|
-36 milligrams per deciliter (mg/dl)
Interval -88.0 to -14.0
|
43 milligrams per deciliter (mg/dl)
Interval 8.0 to 87.0
|
12 milligrams per deciliter (mg/dl)
Interval -18.0 to 54.0
|
4 milligrams per deciliter (mg/dl)
Interval -45.0 to 28.0
|
2 milligrams per deciliter (mg/dl)
Interval -26.0 to 44.0
|
49 milligrams per deciliter (mg/dl)
Interval -26.0 to 161.0
|
12 milligrams per deciliter (mg/dl)
Interval -4.0 to 33.0
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
39 milligrams per deciliter (mg/dl)
Interval 4.0 to 97.0
|
98 milligrams per deciliter (mg/dl)
Interval 34.0 to 163.0
|
-7 milligrams per deciliter (mg/dl)
Interval -165.0 to 57.0
|
7 milligrams per deciliter (mg/dl)
Interval -35.0 to 49.0
|
66 milligrams per deciliter (mg/dl)
Interval -33.0 to 160.0
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59
|
3 milligrams per deciliter (mg/dl)
Interval -32.0 to 13.0
|
53 milligrams per deciliter (mg/dl)
Interval 26.0 to 77.0
|
10 milligrams per deciliter (mg/dl)
Interval -6.0 to 26.0
|
14 milligrams per deciliter (mg/dl)
Interval -9.0 to 34.0
|
52 milligrams per deciliter (mg/dl)
Interval 23.0 to 70.0
|
13 milligrams per deciliter (mg/dl)
Interval -12.0 to 33.0
|
8 milligrams per deciliter (mg/dl)
Interval -13.0 to 22.0
|
22 milligrams per deciliter (mg/dl)
Interval -14.0 to 44.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44
|
-3 milligrams per deciliter (mg/dl)
Interval -16.0 to 25.0
|
46 milligrams per deciliter (mg/dl)
Interval 21.0 to 68.0
|
8 milligrams per deciliter (mg/dl)
Interval -14.0 to 23.0
|
12 milligrams per deciliter (mg/dl)
Interval -15.0 to 26.0
|
39 milligrams per deciliter (mg/dl)
Interval 19.0 to 58.0
|
10 milligrams per deciliter (mg/dl)
Interval -13.0 to 38.0
|
13 milligrams per deciliter (mg/dl)
Interval -9.0 to 32.0
|
19 milligrams per deciliter (mg/dl)
Interval 1.0 to 57.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40
|
-9 milligrams per deciliter (mg/dl)
Interval -17.0 to 9.0
|
50 milligrams per deciliter (mg/dl)
Interval 23.0 to 73.0
|
9 milligrams per deciliter (mg/dl)
Interval -15.0 to 23.0
|
11 milligrams per deciliter (mg/dl)
Interval -16.0 to 25.0
|
42 milligrams per deciliter (mg/dl)
Interval 22.0 to 64.0
|
22 milligrams per deciliter (mg/dl)
Interval -8.0 to 31.0
|
13 milligrams per deciliter (mg/dl)
Interval -10.0 to 30.0
|
32 milligrams per deciliter (mg/dl)
Interval 12.0 to 44.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40
|
14 milligrams per deciliter (mg/dl)
Interval -23.0 to 32.0
|
47 milligrams per deciliter (mg/dl)
Interval 18.0 to 82.0
|
13 milligrams per deciliter (mg/dl)
Interval -10.0 to 38.0
|
14 milligrams per deciliter (mg/dl)
Interval -13.0 to 30.0
|
43 milligrams per deciliter (mg/dl)
Interval 22.0 to 72.0
|
-4 milligrams per deciliter (mg/dl)
Interval -24.0 to 30.0
|
2 milligrams per deciliter (mg/dl)
Interval -12.0 to 27.0
|
12 milligrams per deciliter (mg/dl)
Interval -38.0 to 41.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33
|
6 milligrams per deciliter (mg/dl)
Interval -18.0 to 38.0
|
47 milligrams per deciliter (mg/dl)
Interval 18.0 to 76.0
|
21 milligrams per deciliter (mg/dl)
Interval -4.0 to 60.0
|
18 milligrams per deciliter (mg/dl)
Interval -15.0 to 34.0
|
56 milligrams per deciliter (mg/dl)
Interval 28.0 to 78.0
|
9 milligrams per deciliter (mg/dl)
Interval -22.0 to 31.0
|
6 milligrams per deciliter (mg/dl)
Interval -1.0 to 23.0
|
28 milligrams per deciliter (mg/dl)
Interval 19.0 to 52.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40
|
-4 milligrams per deciliter (mg/dl)
Interval -16.0 to 28.0
|
53 milligrams per deciliter (mg/dl)
Interval 24.0 to 78.0
|
19 milligrams per deciliter (mg/dl)
Interval -4.0 to 40.0
|
3 milligrams per deciliter (mg/dl)
Interval -8.0 to 34.0
|
54 milligrams per deciliter (mg/dl)
Interval 22.0 to 73.0
|
9 milligrams per deciliter (mg/dl)
Interval -19.0 to 27.0
|
5 milligrams per deciliter (mg/dl)
Interval -1.0 to 17.0
|
43 milligrams per deciliter (mg/dl)
Interval 1.0 to 61.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40
|
5 milligrams per deciliter (mg/dl)
Interval -32.0 to 22.0
|
53 milligrams per deciliter (mg/dl)
Interval 22.0 to 80.0
|
22 milligrams per deciliter (mg/dl)
Interval -18.0 to 61.0
|
-3 milligrams per deciliter (mg/dl)
Interval -38.0 to 18.0
|
52 milligrams per deciliter (mg/dl)
Interval 18.0 to 76.0
|
11 milligrams per deciliter (mg/dl)
Interval -9.0 to 36.0
|
-5 milligrams per deciliter (mg/dl)
Interval -12.0 to 14.0
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
47 milligrams per deciliter (mg/dl)
Interval 24.0 to 70.0
|
30 milligrams per deciliter (mg/dl)
Interval 24.0 to 35.0
|
-65 milligrams per deciliter (mg/dl)
Interval -82.0 to -48.0
|
52 milligrams per deciliter (mg/dl)
Interval 25.0 to 79.0
|
28 milligrams per deciliter (mg/dl)
Interval -8.0 to 34.0
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59,
|
-0.2 milligrams per deciliter (mg/dl)
Interval -5.0 to 5.0
|
8 milligrams per deciliter (mg/dl)
Interval 2.0 to 15.0
|
3 milligrams per deciliter (mg/dl)
Interval -5.0 to 8.0
|
6 milligrams per deciliter (mg/dl)
Interval -1.0 to 10.0
|
10 milligrams per deciliter (mg/dl)
Interval 4.0 to 18.0
|
2 milligrams per deciliter (mg/dl)
Interval -4.0 to 11.0
|
3 milligrams per deciliter (mg/dl)
Interval -3.0 to 8.0
|
8 milligrams per deciliter (mg/dl)
Interval 5.0 to 13.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44
|
8 milligrams per deciliter (mg/dl)
Interval 1.0 to 16.0
|
12 milligrams per deciliter (mg/dl)
Interval 4.0 to 19.0
|
4 milligrams per deciliter (mg/dl)
Interval -2.0 to 10.0
|
6 milligrams per deciliter (mg/dl)
Interval -1.0 to 12.0
|
12 milligrams per deciliter (mg/dl)
Interval 4.0 to 18.0
|
2 milligrams per deciliter (mg/dl)
Interval -6.0 to 10.0
|
4 milligrams per deciliter (mg/dl)
Interval -3.0 to 8.0
|
5 milligrams per deciliter (mg/dl)
Interval 4.0 to 13.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40
|
5 milligrams per deciliter (mg/dl)
Interval 1.0 to 11.0
|
12 milligrams per deciliter (mg/dl)
Interval 3.0 to 20.0
|
7 milligrams per deciliter (mg/dl)
Interval 0.0 to 15.0
|
8 milligrams per deciliter (mg/dl)
Interval 1.0 to 13.0
|
12 milligrams per deciliter (mg/dl)
Interval 6.0 to 17.0
|
4 milligrams per deciliter (mg/dl)
Interval -2.0 to 9.0
|
5 milligrams per deciliter (mg/dl)
Interval -6.0 to 11.0
|
10 milligrams per deciliter (mg/dl)
Interval 9.0 to 20.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40
|
6 milligrams per deciliter (mg/dl)
Interval -1.0 to 13.0
|
12 milligrams per deciliter (mg/dl)
Interval 7.0 to 20.0
|
9 milligrams per deciliter (mg/dl)
Interval 3.0 to 17.0
|
6 milligrams per deciliter (mg/dl)
Interval 3.0 to 15.0
|
13 milligrams per deciliter (mg/dl)
Interval 4.0 to 21.0
|
5 milligrams per deciliter (mg/dl)
Interval -2.0 to 12.0
|
3 milligrams per deciliter (mg/dl)
Interval -6.0 to 11.0
|
16 milligrams per deciliter (mg/dl)
Interval 12.0 to 22.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0
|
13 milligrams per deciliter (mg/dl)
Interval 3.0 to 21.0
|
17 milligrams per deciliter (mg/dl)
Interval 6.0 to 24.0
|
12 milligrams per deciliter (mg/dl)
Interval 3.0 to 17.0
|
8 milligrams per deciliter (mg/dl)
Interval -1.0 to 15.0
|
17 milligrams per deciliter (mg/dl)
Interval 9.0 to 24.0
|
2 milligrams per deciliter (mg/dl)
Interval -5.0 to 8.0
|
10 milligrams per deciliter (mg/dl)
Interval 3.0 to 14.0
|
5 milligrams per deciliter (mg/dl)
Interval 4.0 to 24.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40
|
4 milligrams per deciliter (mg/dl)
Interval 1.0 to 16.0
|
15 milligrams per deciliter (mg/dl)
Interval 7.0 to 25.0
|
10 milligrams per deciliter (mg/dl)
Interval 3.0 to 17.0
|
7 milligrams per deciliter (mg/dl)
Interval 1.0 to 12.0
|
17 milligrams per deciliter (mg/dl)
Interval 9.0 to 24.0
|
4 milligrams per deciliter (mg/dl)
Interval -4.0 to 9.0
|
12 milligrams per deciliter (mg/dl)
Only one participant was analyzed in this arm at this time point.
|
18 milligrams per deciliter (mg/dl)
Interval 15.0 to 26.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40
|
10 milligrams per deciliter (mg/dl)
Interval -0.2 to 16.0
|
17 milligrams per deciliter (mg/dl)
Interval 10.0 to 26.0
|
15 milligrams per deciliter (mg/dl)
Interval 2.0 to 22.0
|
6 milligrams per deciliter (mg/dl)
Interval -0.19 to 15.0
|
16 milligrams per deciliter (mg/dl)
Interval 8.0 to 26.0
|
2 milligrams per deciliter (mg/dl)
Interval -7.0 to 12.0
|
3 milligrams per deciliter (mg/dl)
Only one participant was analyzed in this arm at this time point.
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37
|
-2 milligrams per deciliter (mg/dl)
Interval -10.0 to 12.0
|
21 milligrams per deciliter (mg/dl)
Interval 4.0 to 45.0
|
1 milligrams per deciliter (mg/dl)
Interval -20.0 to 17.0
|
3 milligrams per deciliter (mg/dl)
Interval -20.0 to 15.0
|
25 milligrams per deciliter (mg/dl)
Interval 9.0 to 40.0
|
0 milligrams per deciliter (mg/dl)
Interval -18.0 to 27.0
|
7 milligrams per deciliter (mg/dl)
Interval -12.0 to 25.0
|
15 milligrams per deciliter (mg/dl)
Interval 13.0 to 45.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40
|
-4 milligrams per deciliter (mg/dl)
Interval -11.0 to 8.0
|
21 milligrams per deciliter (mg/dl)
Interval 3.0 to 41.0
|
-2 milligrams per deciliter (mg/dl)
Interval -21.0 to 11.0
|
-6 milligrams per deciliter (mg/dl)
Interval -20.0 to 8.0
|
27 milligrams per deciliter (mg/dl)
Interval 10.0 to 44.0
|
12 milligrams per deciliter (mg/dl)
Interval -19.0 to 25.0
|
3 milligrams per deciliter (mg/dl)
Interval -9.0 to 22.0
|
38 milligrams per deciliter (mg/dl)
Interval 22.0 to 61.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34
|
11 milligrams per deciliter (mg/dl)
Interval -20.0 to 18.0
|
24 milligrams per deciliter (mg/dl)
Interval -3.0 to 43.0
|
4 milligrams per deciliter (mg/dl)
Interval -25.0 to 19.0
|
-4 milligrams per deciliter (mg/dl)
Interval -27.0 to 20.0
|
25 milligrams per deciliter (mg/dl)
Interval 10.0 to 42.0
|
-2 milligrams per deciliter (mg/dl)
Interval -20.0 to 17.0
|
0 milligrams per deciliter (mg/dl)
Interval -22.0 to 20.0
|
14 milligrams per deciliter (mg/dl)
Interval 14.0 to 15.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0
|
-5 milligrams per deciliter (mg/dl)
Interval -17.0 to 20.0
|
18 milligrams per deciliter (mg/dl)
Interval 0.3 to 43.0
|
5 milligrams per deciliter (mg/dl)
Interval -17.0 to 23.0
|
-3 milligrams per deciliter (mg/dl)
Interval -25.0 to 11.0
|
37 milligrams per deciliter (mg/dl)
Interval 13.0 to 54.0
|
-6 milligrams per deciliter (mg/dl)
Interval -27.0 to 22.0
|
-1 milligrams per deciliter (mg/dl)
Interval -8.0 to 2.0
|
48 milligrams per deciliter (mg/dl)
Interval 24.0 to 72.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40
|
1 milligrams per deciliter (mg/dl)
Interval -8.0 to 18.0
|
23 milligrams per deciliter (mg/dl)
Interval 4.0 to 49.0
|
2 milligrams per deciliter (mg/dl)
Interval -18.0 to 14.0
|
-2 milligrams per deciliter (mg/dl)
Interval -16.0 to 17.0
|
27 milligrams per deciliter (mg/dl)
Interval 13.0 to 56.0
|
4 milligrams per deciliter (mg/dl)
Interval -20.0 to 18.0
|
-7 milligrams per deciliter (mg/dl)
Only one participant was analyzed in this arm at this time point.
|
54 milligrams per deciliter (mg/dl)
Interval 48.0 to 60.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40
|
5 milligrams per deciliter (mg/dl)
Interval -24.0 to 19.0
|
22 milligrams per deciliter (mg/dl)
Interval 2.0 to 46.0
|
13 milligrams per deciliter (mg/dl)
Interval -18.0 to 40.0
|
-14 milligrams per deciliter (mg/dl)
Interval -32.0 to 12.0
|
35 milligrams per deciliter (mg/dl)
Interval 8.0 to 51.0
|
1 milligrams per deciliter (mg/dl)
Interval -26.0 to 25.0
|
-45 milligrams per deciliter (mg/dl)
Only one participant was analyzed in this arm at this time point.
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
21 milligrams per deciliter (mg/dl)
Interval -3.0 to 45.0
|
5 milligrams per deciliter (mg/dl)
Interval -15.0 to 26.0
|
-39 milligrams per deciliter (mg/dl)
Interval -66.0 to -23.0
|
33 milligrams per deciliter (mg/dl)
Interval 7.0 to 55.0
|
3 milligrams per deciliter (mg/dl)
Interval -42.0 to 45.0
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59
|
-2 milligrams per deciliter (mg/dl)
Interval -4.0 to 2.0
|
3.6 milligrams per deciliter (mg/dl)
Interval -5.0 to 11.0
|
-4 milligrams per deciliter (mg/dl)
Interval -9.0 to 6.0
|
2 milligrams per deciliter (mg/dl)
Interval -4.0 to 11.0
|
7 milligrams per deciliter (mg/dl)
Interval 0.0 to 16.0
|
7 milligrams per deciliter (mg/dl)
Interval -2.0 to 13.0
|
0 milligrams per deciliter (mg/dl)
Interval -9.0 to 11.0
|
0 milligrams per deciliter (mg/dl)
Interval -16.0 to 7.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44
|
0 milligrams per deciliter (mg/dl)
Interval -5.0 to 4.0
|
1.8 milligrams per deciliter (mg/dl)
Interval -4.0 to 11.0
|
-5 milligrams per deciliter (mg/dl)
Interval -11.0 to 0.0
|
0 milligrams per deciliter (mg/dl)
Interval -9.0 to 9.0
|
4 milligrams per deciliter (mg/dl)
Interval -4.0 to 11.0
|
4 milligrams per deciliter (mg/dl)
Interval -5.0 to 14.0
|
0 milligrams per deciliter (mg/dl)
Interval -11.0 to 7.0
|
-5 milligrams per deciliter (mg/dl)
Interval -11.0 to 5.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40
|
-2 milligrams per deciliter (mg/dl)
Interval -7.0 to 2.0
|
1.8 milligrams per deciliter (mg/dl)
Interval -5.0 to 11.0
|
-9 milligrams per deciliter (mg/dl)
Interval -16.0 to -4.0
|
1 milligrams per deciliter (mg/dl)
Interval -6.0 to 7.0
|
5 milligrams per deciliter (mg/dl)
Interval -2.0 to 14.0
|
2 milligrams per deciliter (mg/dl)
Interval -10.0 to 12.0
|
0 milligrams per deciliter (mg/dl)
Interval -7.0 to 11.0
|
-2 milligrams per deciliter (mg/dl)
Interval -11.0 to 2.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40
|
0 milligrams per deciliter (mg/dl)
Interval -5.0 to 2.0
|
0 milligrams per deciliter (mg/dl)
Interval -7.0 to 11.0
|
-4 milligrams per deciliter (mg/dl)
Interval -5.0 to 4.0
|
0 milligrams per deciliter (mg/dl)
Interval -9.0 to 5.0
|
0 milligrams per deciliter (mg/dl)
Interval -5.0 to 13.0
|
0 milligrams per deciliter (mg/dl)
Interval -10.0 to 7.0
|
7 milligrams per deciliter (mg/dl)
Interval -2.0 to 16.0
|
-14 milligrams per deciliter (mg/dl)
Interval -21.0 to -8.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0
|
1 milligrams per deciliter (mg/dl)
Interval -4.0 to 4.0
|
0 milligrams per deciliter (mg/dl)
Interval -9.0 to 9.0
|
-2 milligrams per deciliter (mg/dl)
Interval -7.0 to 5.0
|
2 milligrams per deciliter (mg/dl)
Interval -4.0 to 7.0
|
4 milligrams per deciliter (mg/dl)
Interval -5.0 to 11.0
|
-3 milligrams per deciliter (mg/dl)
Interval -14.0 to 9.0
|
21 milligrams per deciliter (mg/dl)
Interval 13.0 to 24.0
|
0 milligrams per deciliter (mg/dl)
Interval -2.0 to 2.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40
|
-0.9 milligrams per deciliter (mg/dl)
Interval -4.0 to 1.0
|
2.7 milligrams per deciliter (mg/dl)
Interval -5.0 to 9.0
|
-1.8 milligrams per deciliter (mg/dl)
Interval -7.0 to 7.0
|
2 milligrams per deciliter (mg/dl)
Interval -4.0 to 11.0
|
2 milligrams per deciliter (mg/dl)
Interval -7.0 to 11.0
|
2 milligrams per deciliter (mg/dl)
Interval -6.0 to 7.0
|
20 milligrams per deciliter (mg/dl)
Interval 14.0 to 29.0
|
-1 milligrams per deciliter (mg/dl)
Interval -5.0 to 3.0
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40
|
4 milligrams per deciliter (mg/dl)
Interval -8.0 to 9.0
|
1.8 milligrams per deciliter (mg/dl)
Interval -5.0 to 11.0
|
0 milligrams per deciliter (mg/dl)
Interval -5.0 to 5.0
|
0 milligrams per deciliter (mg/dl)
Interval -7.0 to 7.0
|
2 milligrams per deciliter (mg/dl)
Interval -5.0 to 9.0
|
5 milligrams per deciliter (mg/dl)
Interval -5.0 to 16.0
|
21 milligrams per deciliter (mg/dl)
Interval 14.0 to 25.0
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
|
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
5.4 milligrams per deciliter (mg/dl)
Interval -2.0 to 13.0
|
2 milligrams per deciliter (mg/dl)
Interval -2.0 to 5.0
|
0 milligrams per deciliter (mg/dl)
Interval -7.0 to 16.0
|
0 milligrams per deciliter (mg/dl)
Interval -5.0 to 7.0
|
11 milligrams per deciliter (mg/dl)
Interval -2.0 to 20.0
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
NA milligrams per deciliter (mg/dl)
No participants were analyzed in this arm at this time point.
|
PRIMARY outcome
Timeframe: Weeks 120, 180, 204, 216, and 432Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).
Outcome measures
| Measure |
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=106 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Triglycerides; Week 120, n=14
|
—
|
—
|
—
|
—
|
237 milligrams per deciliter (mg/dl)
Interval 187.0 to 372.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Triglycerides; Week 180, n=14
|
—
|
—
|
—
|
—
|
248 milligrams per deciliter (mg/dl)
Interval 193.0 to 312.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Triglycerides; Week 204, n=106
|
—
|
—
|
—
|
—
|
137 milligrams per deciliter (mg/dl)
Interval 95.0 to 204.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Triglycerides; Week 216, n=102
|
—
|
—
|
—
|
—
|
120 milligrams per deciliter (mg/dl)
Interval 92.0 to 192.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Triglycerides; Week 432, n=40
|
—
|
—
|
—
|
—
|
132 milligrams per deciliter (mg/dl)
Interval 76.0 to 182.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Cholesterol; Week 120, n=14
|
—
|
—
|
—
|
—
|
202 milligrams per deciliter (mg/dl)
Interval 183.0 to 284.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Cholesterol; Week 180, n=14
|
—
|
—
|
—
|
—
|
206 milligrams per deciliter (mg/dl)
Interval 20.0 to 226.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Cholesterol; Week 204, n=106
|
—
|
—
|
—
|
—
|
201 milligrams per deciliter (mg/dl)
Interval 166.0 to 232.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Cholesterol; Week 216, n=102
|
—
|
—
|
—
|
—
|
205 milligrams per deciliter (mg/dl)
Interval 169.0 to 239.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Cholesterol; Week 432, n=40
|
—
|
—
|
—
|
—
|
192 milligrams per deciliter (mg/dl)
Interval 168.0 to 233.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
HDL Cholesterol; Week 120, n=14
|
—
|
—
|
—
|
—
|
40 milligrams per deciliter (mg/dl)
Interval 34.0 to 45.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
HDL Cholesterol; Week 180, n=14
|
—
|
—
|
—
|
—
|
36 milligrams per deciliter (mg/dl)
Interval 34.0 to 47.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
HDL Cholesterol; Week 204, n=106
|
—
|
—
|
—
|
—
|
52 milligrams per deciliter (mg/dl)
Interval 42.0 to 61.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
HDL Cholesterol; Week 216, n=102
|
—
|
—
|
—
|
—
|
51 milligrams per deciliter (mg/dl)
Interval 44.0 to 62.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
HDL Cholesterol; Week 432, n=40
|
—
|
—
|
—
|
—
|
51 milligrams per deciliter (mg/dl)
Interval 44.0 to 57.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
LDL Cholesterol; Week 120, n=14
|
—
|
—
|
—
|
—
|
40 milligrams per deciliter (mg/dl)
Interval 34.0 to 45.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
LDL Cholesterol; Week 180, n=14
|
—
|
—
|
—
|
—
|
40 milligrams per deciliter (mg/dl)
Interval 34.0 to 48.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
LDL Cholesterol; Week 204, n=106
|
—
|
—
|
—
|
—
|
52 milligrams per deciliter (mg/dl)
Interval 42.0 to 61.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
LDL Cholesterol; Week 216, n=102
|
—
|
—
|
—
|
—
|
51 milligrams per deciliter (mg/dl)
Interval 44.0 to 62.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
LDL Cholesterol; Week 432, n=40
|
—
|
—
|
—
|
—
|
51 milligrams per deciliter (mg/dl)
Interval 44.0 to 57.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
FBG; Week 120, n=14
|
—
|
—
|
—
|
—
|
86 milligrams per deciliter (mg/dl)
Interval 79.0 to 97.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
FBG; Week 180, n=14
|
—
|
—
|
—
|
—
|
88 milligrams per deciliter (mg/dl)
Interval 85.0 to 92.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
FBG; Week 204, n=106
|
—
|
—
|
—
|
—
|
92 milligrams per deciliter (mg/dl)
Interval 81.0 to 97.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
FBG; Week 216, n=104
|
—
|
—
|
—
|
—
|
90 milligrams per deciliter (mg/dl)
Interval 81.0 to 97.0
|
—
|
—
|
—
|
|
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
FBG Cholesterol; Week 432, n=40
|
—
|
—
|
—
|
—
|
92 milligrams per deciliter (mg/dl)
Interval 83.0 to 100.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.
blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Outcome measures
| Measure |
NFV Population (APV30001)
n=14 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=159 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=38 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=84 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
Week 48, n=54, 14, 159, 38
|
-0.4 ratio
Interval -1.0 to 0.6
|
0.4 ratio
Interval -0.3 to 1.2
|
0.1 ratio
Interval -0.3 to 0.5
|
—
|
0.1 ratio
Interval -0.4 to 0.8
|
—
|
—
|
—
|
|
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
Week 120, n=84, 14, 137, 33
|
-0.6 ratio
Interval -1.1 to -0.2
|
-0.1 ratio
Interval -0.8 to 0.7
|
-0.2 ratio
Interval -0.7 to 0.1
|
—
|
-0.2 ratio
Interval -0.7 to 0.4
|
—
|
—
|
—
|
|
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
Week 180, n=73, 12, 114, 30
|
-0.6 ratio
Interval -1.6 to 0.1
|
-0.3 ratio
Interval -1.0 to 0.4
|
-0.3 ratio
Interval -1.3 to 0.0
|
—
|
-0.4 ratio
Interval -1.1 to 0.2
|
—
|
—
|
—
|
|
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
Week 204, n=73, 12, 113, 23
|
-0.6 ratio
Interval -1.7 to 0.1
|
-0.4 ratio
Interval -1.0 to 0.1
|
-0.4 ratio
Interval -0.9 to 0.23
|
—
|
-0.3 ratio
Interval -1.0 to 0.1
|
—
|
—
|
—
|
|
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
Week 216, n=76, 0, 111, 2
|
NA ratio
No participants were analyzed in this arm at this time point.
|
-0.5 ratio
Interval -1.1 to 0.1
|
0.3 ratio
Interval 0.1 to 0.6
|
—
|
-0.5 ratio
Interval -1.0 to 0.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Weeks 48, 96, 132, and 168Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Outcome measures
| Measure |
NFV Population (APV30001)
n=65 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=45 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=7 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=61 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Week 48, n=61, 65 , 45, 7
|
-0.3 ratio
Interval -1.1 to 0.8
|
-0.1 ratio
Interval -0.8 to 0.8
|
-0.8 ratio
Interval -0.8 to -0.1
|
—
|
-0.4 ratio
Interval -1.1 to 0.4
|
—
|
—
|
—
|
|
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Week 96, n=47, 52, 42, 5
|
0.1 ratio
Interval -0.8 to 0.8
|
-0.1 ratio
Interval -0.7 to 0.4
|
-0.3 ratio
Interval -0.5 to 0.0
|
—
|
-0.5 ratio
Interval -1.4 to 0.0
|
—
|
—
|
—
|
|
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Week 132, n=40, 44, 41, 4
|
-0.6 ratio
Interval -1.6 to 0.5
|
-0.2 ratio
Interval -1.1 to 1.0
|
-1.5 ratio
Interval -2.7 to -0.3
|
—
|
-0.4 ratio
Interval -1.5 to -0.1
|
—
|
—
|
—
|
|
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Week 168, n=31, 40, 3, 5
|
0.2 ratio
Interval -1.0 to 0.5
|
-0.6 ratio
Interval -1.0 to -0.4
|
-1.4 ratio
Interval -1.4 to 0.1
|
—
|
-0.3 ratio
Interval -1.4 to 0.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Weeks 120, 180, 204, 216, and 432Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.
Outcome measures
| Measure |
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=106 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Week 120, n=14
|
—
|
—
|
—
|
—
|
5.5 ratio
Interval 4.5 to 5.8
|
—
|
—
|
—
|
|
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Week 180, n=14
|
—
|
—
|
—
|
—
|
5.5 ratio
Interval 4.7 to 6.0
|
—
|
—
|
—
|
|
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Week 204, n=106
|
—
|
—
|
—
|
—
|
3.7 ratio
Interval 3.0 to 4.8
|
—
|
—
|
—
|
|
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Week 216, n=102
|
—
|
—
|
—
|
—
|
3.5 ratio
Interval 3.0 to 4.5
|
—
|
—
|
—
|
|
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Week 432, n=40
|
—
|
—
|
—
|
—
|
4.0 ratio
Interval 3.3 to 4.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Outcome measures
| Measure |
NFV Population (APV30001)
n=17 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=217 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=47 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=118 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
AST; Week 48, n=117, 17, 215, 47
|
-2 units per liter (U/L)
Interval -3.0 to 5.0
|
-7 units per liter (U/L)
Interval -17.0 to -1.0
|
0 units per liter (U/L)
Interval -5.0 to 5.0
|
—
|
-7 units per liter (U/L)
Interval -14.0 to -1.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
AST; Week 120, n=96, 15, 182, 40
|
0 units per liter (U/L)
Interval -8.0 to 4.0
|
-8 units per liter (U/L)
Interval -19.0 to -2.0
|
1 units per liter (U/L)
Interval -3.0 to 4.0
|
—
|
-8 units per liter (U/L)
Interval -19.0 to -1.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
AST; Week 180, n=80, 12, 154, 33
|
2 units per liter (U/L)
Interval -5.0 to 4.0
|
-7 units per liter (U/L)
Interval -18.0 to -1.0
|
-2 units per liter (U/L)
Interval -4.0 to 2.0
|
—
|
-10 units per liter (U/L)
Interval -19.0 to -3.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
AST; Week 204, n=77, 12, 151, 27
|
3 units per liter (U/L)
Interval -4.0 to 6.0
|
-7 units per liter (U/L)
Interval -18.0 to -1.0
|
-2 units per liter (U/L)
Interval -4.0 to 2.0
|
—
|
-7 units per liter (U/L)
Interval -18.0 to -1.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
AST; Week 216, n=79, 0, 142, 4
|
NA units per liter (U/L)
No participants were analyzed in this arm at this time point.
|
-7 units per liter (U/L)
Interval -17.0 to 0.0
|
1 units per liter (U/L)
Interval -7.0 to 8.0
|
—
|
-9 units per liter (U/L)
Interval -16.0 to -1.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
ALT; Week 48, n=117, 17, 216, 47
|
0 units per liter (U/L)
Interval -3.0 to 4.0
|
-8 units per liter (U/L)
Interval -19.0 to 1.0
|
2 units per liter (U/L)
Interval -2.0 to 8.0
|
—
|
-5 units per liter (U/L)
Interval -21.0 to 2.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
ALT; Week 120, n=96, 15, 182, 40
|
-1 units per liter (U/L)
Interval -6.0 to 7.0
|
-8 units per liter (U/L)
Interval -20.0 to 0.0
|
4 units per liter (U/L)
Interval -6.0 to 8.0
|
—
|
-9 units per liter (U/L)
Interval -29.0 to 2.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
ALT; Week 180, n=81, 12, 155, 33
|
3 units per liter (U/L)
Interval -3.0 to 5.0
|
-6 units per liter (U/L)
Interval -19.0 to 5.0
|
1 units per liter (U/L)
Interval -5.0 to 6.0
|
—
|
-10 units per liter (U/L)
Interval -27.0 to -1.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
ALT; Week 204, n=77, 12, 152, 27
|
2 units per liter (U/L)
Interval -1.0 to 9.0
|
-5 units per liter (U/L)
Interval -19.0 to 4.0
|
-1 units per liter (U/L)
Interval -7.0 to 5.0
|
—
|
-10 units per liter (U/L)
Interval -26.0 to 0.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
ALT; Week 216, n=79, 0, 142, 4
|
NA units per liter (U/L)
No participants were analyzed in this arm at this time point.
|
-6 units per liter (U/L)
Interval -18.0 to 2.0
|
-3 units per liter (U/L)
Interval -11.0 to 9.0
|
—
|
-10 units per liter (U/L)
Interval -27.0 to 2.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Serum lipase; Week 48, n=118, 17, 217, 47
|
1 units per liter (U/L)
Interval -8.0 to 5.0
|
0 units per liter (U/L)
Interval -7.0 to 7.0
|
-2 units per liter (U/L)
Interval -6.0 to 1.0
|
—
|
4 units per liter (U/L)
Interval -2.0 to 10.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Serum lipase; Week 120, n=95, 15, 184, 40
|
4 units per liter (U/L)
Interval -1.0 to 6.0
|
-1 units per liter (U/L)
Interval -6.0 to 6.0
|
2 units per liter (U/L)
Interval -4.0 to 7.0
|
—
|
4 units per liter (U/L)
Interval -4.0 to 9.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Serum lipase; Week 180, n=81, 12, 156, 33
|
-0.5 units per liter (U/L)
Interval -6.0 to 4.0
|
1 units per liter (U/L)
Interval -5.0 to 6.0
|
1 units per liter (U/L)
Interval -5.0 to 3.0
|
—
|
4 units per liter (U/L)
Interval -3.0 to 9.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Serum lipase;Week 204, n=78, 12, 153, 27
|
0 units per liter (U/L)
Interval -5.0 to 3.0
|
1 units per liter (U/L)
Interval -5.0 to 7.0
|
2 units per liter (U/L)
Interval -4.0 to 6.0
|
—
|
3 units per liter (U/L)
Interval -4.0 to 10.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Serum lipase; Week 216, n=80, 0, 143, 4
|
NA units per liter (U/L)
No participants were analyzed in this arm at this time point.
|
0 units per liter (U/L)
Interval -6.0 to 9.0
|
-3 units per liter (U/L)
Interval -27.0 to 5.0
|
—
|
5 units per liter (U/L)
Interval -2.0 to 11.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Weeks 48, 96, 132, and 168Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Outcome measures
| Measure |
NFV Population (APV30001)
n=78 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=83 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=65 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=73 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
AST; Week 48, n=73, 78, 83, 65
|
-5 units per liter (U/L)
Interval -15.0 to -1.0
|
1 units per liter (U/L)
Interval -3.0 to 4.0
|
0 units per liter (U/L)
Interval -6.0 to 6.0
|
—
|
-6 units per liter (U/L)
Interval -14.0 to 3.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
AST; Week 96, n=57, 63, 73, 49
|
-4 units per liter (U/L)
Interval -18.0 to 2.0
|
1 units per liter (U/L)
Interval -3.0 to 3.0
|
-1 units per liter (U/L)
Interval -9.0 to 4.0
|
—
|
-6 units per liter (U/L)
Interval -12.0 to 6.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
AST; Week 132, n=50, 57, 64, 46
|
-4 units per liter (U/L)
Interval -14.0 to 2.0
|
2 units per liter (U/L)
Interval -3.0 to 5.0
|
1 units per liter (U/L)
Interval -5.0 to 8.0
|
—
|
-6 units per liter (U/L)
Interval -13.0 to -1.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
AST; Week 168, n=45, 48, 20, 36
|
-6 units per liter (U/L)
Interval -17.0 to -1.0
|
2 units per liter (U/L)
Interval -1.0 to 5.0
|
-1 units per liter (U/L)
Interval -10.0 to 5.0
|
—
|
-6 units per liter (U/L)
Interval -14.0 to 1.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
ALT; Week 48, n=70, 78, 83, 65
|
-6 units per liter (U/L)
Interval -21.0 to 1.0
|
2 units per liter (U/L)
Interval -2.0 to 8.0
|
0 units per liter (U/L)
Interval -9.0 to 12.0
|
—
|
-2 units per liter (U/L)
Interval -13.0 to 4.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
ALT; Week 96, n=59, 63, 73, 49
|
-3 units per liter (U/L)
Interval -21.0 to 3.0
|
2 units per liter (U/L)
Interval -3.0 to 6.0
|
1 units per liter (U/L)
Interval -10.0 to 6.0
|
—
|
-4 units per liter (U/L)
Interval -13.0 to 9.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
ALT; Week 132, n=51, 58, 64, 46
|
-4 units per liter (U/L)
Interval -18.0 to 3.0
|
2 units per liter (U/L)
Interval -2.0 to 8.0
|
2 units per liter (U/L)
Interval -10.0 to 8.0
|
—
|
-2 units per liter (U/L)
Interval -17.0 to 8.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
ALT; Week 168, n=45, 48, 20, 37
|
-5 units per liter (U/L)
Interval -22.0 to 4.0
|
6 units per liter (U/L)
Interval -1.0 to 9.0
|
-3 units per liter (U/L)
Interval -16.0 to 6.0
|
—
|
-5 units per liter (U/L)
Interval -23.0 to 4.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Serum lipase; Week 48, n=72, 78, 57, 64
|
2 units per liter (U/L)
Interval -4.0 to 9.0
|
1 units per liter (U/L)
Interval -3.0 to 7.0
|
1 units per liter (U/L)
Interval -4.0 to 6.0
|
—
|
1 units per liter (U/L)
Interval -5.0 to 8.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Serum lipase; Week 96, n=59, 63, 52, 49
|
4 units per liter (U/L)
Interval -5.0 to 12.0
|
0 units per liter (U/L)
Interval -3.0 to 3.0
|
3 units per liter (U/L)
Interval -4.0 to 11.0
|
—
|
3 units per liter (U/L)
Interval -4.0 to 10.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Serum lipase; Week 132, n=52, 58, 47, 46
|
4 units per liter (U/L)
Interval -1.0 to 13.0
|
1 units per liter (U/L)
Interval -3.0 to 5.0
|
2 units per liter (U/L)
Interval -4.0 to 11.0
|
—
|
2 units per liter (U/L)
Interval -4.0 to 10.0
|
—
|
—
|
—
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Serum lipase; Week 168, n=45, 48, 7, 37
|
2 units per liter (U/L)
Interval -1.0 to 11.0
|
-5 units per liter (U/L)
Interval -14.0 to 8.0
|
3 units per liter (U/L)
Interval -6.0 to 16.0
|
—
|
0 units per liter (U/L)
Interval -8.0 to 6.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Weeks 120, 180, 204, 216, and 432Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.
Outcome measures
| Measure |
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=107 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
ALT; Week 216, n=106
|
—
|
—
|
—
|
—
|
19 units per liter (U/L)
Interval 14.0 to 25.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
AST; Week 120, n=14
|
—
|
—
|
—
|
—
|
18 units per liter (U/L)
Interval 17.0 to 22.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
AST; Week 180, n=14
|
—
|
—
|
—
|
—
|
21 units per liter (U/L)
Interval 19.0 to 23.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
AST; Week 204, n=107
|
—
|
—
|
—
|
—
|
20 units per liter (U/L)
Interval 16.0 to 23.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
AST; Week 216, n=106
|
—
|
—
|
—
|
—
|
21 units per liter (U/L)
Interval 18.0 to 25.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
AST; Week 432, n=41
|
—
|
—
|
—
|
—
|
21 units per liter (U/L)
Interval 17.0 to 24.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
ALT; Week 120, n=14
|
—
|
—
|
—
|
—
|
18 units per liter (U/L)
Interval 14.0 to 27.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
ALT; Week 180, n=14
|
—
|
—
|
—
|
—
|
32 units per liter (U/L)
Interval 22.0 to 36.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
ALT; Week 204, n=107
|
—
|
—
|
—
|
—
|
19 units per liter (U/L)
Interval 13.0 to 25.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
ALT; Week 432, n=41
|
—
|
—
|
—
|
—
|
19 units per liter (U/L)
Interval 15.0 to 24.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Serum lipase;Week 120, n=14
|
—
|
—
|
—
|
—
|
47 units per liter (U/L)
Interval 31.0 to 53.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Serum lipase; Week 180, n=14
|
—
|
—
|
—
|
—
|
39 units per liter (U/L)
Interval 29.0 to 49.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Serum lipase; Week 204, n=107
|
—
|
—
|
—
|
—
|
34 units per liter (U/L)
Interval 27.0 to 44.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Serum lipase; Week 216, n=106
|
—
|
—
|
—
|
—
|
36 units per liter (U/L)
Interval 26.0 to 43.0
|
—
|
—
|
—
|
|
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Serum lipase; Week 432, n=41
|
—
|
—
|
—
|
—
|
36 units per liter (U/L)
Interval 30.0 to 47.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 48, 120, 180, and 216Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. No participants were analyzed in the NPV APV30001 arm due to their small number.
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
Outcome measures
| Measure |
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=221 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=54 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=119 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Baseline <400 copies, n=119, 219, 54; MD=F
|
—
|
0 percentage of participants
|
61 percentage of participants
|
—
|
1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 48 <400 copies, n=119, 219, 54; MD=F
|
—
|
94 percentage of participants
|
85 percentage of participants
|
—
|
92 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 120 <400 copies, n=119, 219, 54; MD=F
|
—
|
77 percentage of participants
|
69 percentage of participants
|
—
|
76 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 180 <400 copies, n=119, 219, 54; MD=F
|
—
|
68 percentage of participants
|
54 percentage of participants
|
—
|
66 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 216 <400 copies, n=119, 219, 0; MD=F
|
—
|
61 percentage of participants
|
NA percentage of participants
No participants were analyzed in this arm at this time point.
|
—
|
62 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Baseline <400 copies, n=119, 219, 54; observed
|
—
|
0 percentage of participants
|
61 percentage of participants
|
—
|
1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 48 <400 copies, n=118, 216, 49; observed
|
—
|
95 percentage of participants
|
94 percentage of participants
|
—
|
93 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 120 <400 copies, n=96, 181, 40; observed
|
—
|
93 percentage of participants
|
93 percentage of participants
|
—
|
95 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 180 <400 copies, n=82, 158, 34; observed
|
—
|
94 percentage of participants
|
85 percentage of participants
|
—
|
95 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 216 <400 copies, n=80, 142, 0; observed
|
—
|
94 percentage of participants
|
NA percentage of participants
No participants were analyzed in this arm at this time point.
|
—
|
93 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Baseline <50 copies, n=119, 219, 54; MD=F
|
—
|
0 percentage of participants
|
46 percentage of participants
|
—
|
1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 48 <50 copies, n=119, 219, 54; MD=F
|
—
|
76 percentage of participants
|
59 percentage of participants
|
—
|
80 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 120 <50 copies, n=119, 219, 54; MD=F
|
—
|
66 percentage of participants
|
61 percentage of participants
|
—
|
71 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 180 <50 copies, n=119, 219, 54; MD=F
|
—
|
63 percentage of participants
|
48 percentage of participants
|
—
|
61 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 216 <50 copies, n=119, 219, 0; MD=F
|
—
|
58 percentage of participants
|
NA percentage of participants
No participants were analyzed in this arm at this time point.
|
—
|
58 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Baseline <50 copies, n=119, 219, 54; observed
|
—
|
0 percentage of participants
|
46 percentage of participants
|
—
|
1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 48 <50 copies, n=118, 216, 49; observed
|
—
|
77 percentage of participants
|
65 percentage of participants
|
—
|
81 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 120 <50 copies, n=96, 181, 40; observed
|
—
|
80 percentage of participants
|
83 percentage of participants
|
—
|
88 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 180 <50 copies, n=82, 158, 34; observed
|
—
|
88 percentage of participants
|
76 percentage of participants
|
—
|
88 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Week 216 <50 copies, n=80, 142, 0; observed
|
—
|
89 percentage of participants
|
NA percentage of participants
No participants were analyzed in this arm at this time point.
|
—
|
86 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 48, 60, 96, and 132Population: All participants receiving FPV or FPV/RTV in Study APV3005 having participated in Study APV30003 or other studies. The PI-naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.
Outcome measures
| Measure |
NFV Population (APV30001)
n=78 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=104 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=86 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=73 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Baseline <400 copies, n=73, 78, 104, 86; MD=F
|
1 percentage of participants
|
84 percentage of participants
|
59 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 12 <400 copies, n=73, 78, 104, 86; MD=F
|
82 percentage of participants
|
82 percentage of participants
|
52 percentage of participants
|
—
|
75 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 24 <400 copies, n=73, 78, 104, 86; MD=F
|
79 percentage of participants
|
85 percentage of participants
|
60 percentage of participants
|
—
|
79 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 48 <400 copies, n=73, 78, 104, 86; MD=F
|
78 percentage of participants
|
78 percentage of participants
|
50 percentage of participants
|
—
|
71 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 60 <400 copies, n=73, 78, 104, 86; MD=F
|
77 percentage of participants
|
74 percentage of participants
|
51 percentage of participants
|
—
|
70 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 96 <400 copies, n=73, 78, 104, 86; MD=F
|
62 percentage of participants
|
67 percentage of participants
|
45 percentage of participants
|
—
|
58 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 132 <400 copies, n=73, 78, 104, 86; MD=F
|
60 percentage of participants
|
60 percentage of participants
|
41 percentage of participants
|
—
|
49 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Baseline <400 copies, n=73, 78, 92, 82; observed
|
1 percentage of participants
|
95 percentage of participants
|
62 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 12 <400 copies, n=69, 78, 92, 79; observed
|
82 percentage of participants
|
92 percentage of participants
|
57 percentage of participants
|
—
|
80 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 24 <400 copies, n=73, 75, 93, 79; observed
|
83 percentage of participants
|
95 percentage of participants
|
66 percentage of participants
|
—
|
79 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 48 <400 copies, n=73, 77, 85, 68; observed
|
79 percentage of participants
|
95 percentage of participants
|
63 percentage of participants
|
—
|
71 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 60 <400 copies, n=71, 76, 81, 58; observed
|
79 percentage of participants
|
95 percentage of participants
|
76 percentage of participants
|
—
|
72 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 96 <400 copies, n=60, 62, 75, 51; observed
|
77 percentage of participants
|
93 percentage of participants
|
76 percentage of participants
|
—
|
70 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 132 <400 copies,n=50, 58, 65, 46; observed
|
81 percentage of participants
|
95 percentage of participants
|
76 percentage of participants
|
—
|
72 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Baseline <50 copies, n=73, 78, 104, 86; MD=F
|
0 percentage of participants
|
59 percentage of participants
|
44 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 12 <50 copies, n=73, 78, 104, 86; MD=F
|
47 percentage of participants
|
78 percentage of participants
|
40 percentage of participants
|
—
|
47 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 24 <50 copies, n=73, 78, 104, 86; MD=F
|
64 percentage of participants
|
78 percentage of participants
|
42 percentage of participants
|
—
|
63 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 48 <50 copies, n=73, 78, 104, 86; MD=F
|
60 percentage of participants
|
69 percentage of participants
|
42 percentage of participants
|
—
|
49 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 60 <50 copies, n=73, 78, 104, 86; MD=F
|
59 percentage of participants
|
68 percentage of participants
|
41 percentage of participants
|
—
|
51 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 96 <50 copies, n=73, 78, 104, 86; MD=F
|
51 percentage of participants
|
61 percentage of participants
|
37 percentage of participants
|
—
|
45 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 132 <50 copies, n=73, 78, 104, 86; MD=F
|
45 percentage of participants
|
53 percentage of participants
|
40 percentage of participants
|
—
|
37 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Baseline <50 copies, n=73, 78, 92, 82; observed
|
0 percentage of participants
|
66 percentage of participants
|
46 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 12 <50 copies, n=69, 78, 92, 79; observed
|
47 percentage of participants
|
88 percentage of participants
|
43 percentage of participants
|
—
|
49 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 24 <50 copies, n=73, 75, 93, 79; observed
|
67 percentage of participants
|
87 percentage of participants
|
46 percentage of participants
|
—
|
63 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 48 <50 copies, n=73, 77, 85, 68; observed
|
61 percentage of participants
|
85 percentage of participants
|
53 percentage of participants
|
—
|
49 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 60 <50 copies, n=71, 76, 81, 58; observed
|
61 percentage of participants
|
88 percentage of participants
|
60 percentage of participants
|
—
|
52 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 96 <50 copies, n=60, 62, 75, 51; observed
|
65 percentage of participants
|
84 percentage of participants
|
63 percentage of participants
|
—
|
55 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Week 132 <50 copies, n=50, 58, 65, 46; observed
|
60 percentage of participants
|
85 percentage of participants
|
74 percentage of participants
|
—
|
54 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed. In the observed analysis, data are presented for the number of participants still enrolled in the study who are classified as responders.
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.
Outcome measures
| Measure |
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=101 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Week 120 <50 copies, n=14; observed
|
—
|
—
|
—
|
—
|
93 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Week 180 <50 copies, n=14; observed
|
—
|
—
|
—
|
—
|
86 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Week 240 <50 copies, n=101; observed
|
—
|
—
|
—
|
—
|
87 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Week 300 <50 copies, n=82; observed
|
—
|
—
|
—
|
—
|
93 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Week 360 <50 copies, n=53; observed
|
—
|
—
|
—
|
—
|
89 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Week 420 <50 copies, n=52; observed
|
—
|
—
|
—
|
—
|
92 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Week 432 <50 copies, n=41; observed
|
—
|
—
|
—
|
—
|
93 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 48, 120, 168, 180, 204, and 216Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Outcome measures
| Measure |
NFV Population (APV30001)
n=18 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=219 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=52 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=119 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Baseline, n=119, 18, 219, 52
|
505 cells per millimeters cubed (cells/mm^3)
Interval 179.0 to 1788.0
|
167 cells per millimeters cubed (cells/mm^3)
Interval 1.0 to 813.0
|
297 cells per millimeters cubed (cells/mm^3)
Interval 5.0 to 755.0
|
—
|
211 cells per millimeters cubed (cells/mm^3)
Interval 2.0 to 1136.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Week 48, n=117, 17, 211, 49
|
499 cells per millimeters cubed (cells/mm^3)
Interval 179.0 to 1367.0
|
396 cells per millimeters cubed (cells/mm^3)
Interval 58.0 to 1188.0
|
377 cells per millimeters cubed (cells/mm^3)
Interval 13.0 to 884.0
|
—
|
426 cells per millimeters cubed (cells/mm^3)
Interval 40.0 to 1326.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Week 120, n=95, 15, 177, 40
|
613 cells per millimeters cubed (cells/mm^3)
Interval 274.0 to 1406.0
|
475 cells per millimeters cubed (cells/mm^3)
Interval 90.0 to 1595.0
|
439 cells per millimeters cubed (cells/mm^3)
Interval 124.0 to 888.0
|
—
|
512 cells per millimeters cubed (cells/mm^3)
Interval 116.0 to 1289.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Week 168, n=81, 12, 160, 37
|
608 cells per millimeters cubed (cells/mm^3)
Interval 287.0 to 1069.0
|
506 cells per millimeters cubed (cells/mm^3)
Interval 67.0 to 1299.0
|
422 cells per millimeters cubed (cells/mm^3)
Interval 83.0 to 835.0
|
—
|
594 cells per millimeters cubed (cells/mm^3)
Interval 147.0 to 1534.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Week 180, n=78, 9, 153, 33
|
447 cells per millimeters cubed (cells/mm^3)
Interval 180.0 to 768.0
|
494 cells per millimeters cubed (cells/mm^3)
Interval 113.0 to 1261.0
|
413 cells per millimeters cubed (cells/mm^3)
Interval 129.0 to 970.0
|
—
|
541 cells per millimeters cubed (cells/mm^3)
Interval 418.0 to 765.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Week 204, n=75, 11, 145, 27
|
563 cells per millimeters cubed (cells/mm^3)
Interval 226.0 to 998.0
|
494 cells per millimeters cubed (cells/mm^3)
Interval 110.0 to 1420.0
|
459 cells per millimeters cubed (cells/mm^3)
Interval 115.0 to 911.0
|
—
|
535 cells per millimeters cubed (cells/mm^3)
Interval 377.0 to 709.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Week 216, n=77, 0, 138, 4
|
NA cells per millimeters cubed (cells/mm^3)
No participants were analyzed in this arm at this time point.
|
534 cells per millimeters cubed (cells/mm^3)
Interval 117.0 to 1687.0
|
548 cells per millimeters cubed (cells/mm^3)
Interval 102.0 to 641.0
|
—
|
608 cells per millimeters cubed (cells/mm^3)
Interval 477.0 to 846.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 48, 96, 132, and 168Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 and other studies. Only those participants contributing data at the indicated time points were analyzed. The PI-naїve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Outcome measures
| Measure |
NFV Population (APV30001)
n=78 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=94 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=76 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=73 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Baseline, n=72, 78, 94, 76
|
304 cells per millimeters cubed (cells/mm^3)
Interval 41.0 to 845.0
|
477 cells per millimeters cubed (cells/mm^3)
Interval 130.0 to 1224.0
|
361 cells per millimeters cubed (cells/mm^3)
Interval 6.0 to 1354.0
|
—
|
311 cells per millimeters cubed (cells/mm^3)
Interval 6.0 to 1171.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Week 24, n=71, 73, 92, 75
|
348 cells per millimeters cubed (cells/mm^3)
Interval 101.0 to 1051.0
|
520 cells per millimeters cubed (cells/mm^3)
Interval 128.0 to 1266.0
|
399 cells per millimeters cubed (cells/mm^3)
Interval 28.0 to 1120.0
|
—
|
367 cells per millimeters cubed (cells/mm^3)
Interval 69.0 to 1391.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Week 48, n=73, 77, 85, 68
|
386 cells per millimeters cubed (cells/mm^3)
Interval 99.0 to 965.0
|
582 cells per millimeters cubed (cells/mm^3)
Interval 42.0 to 1194.0
|
418 cells per millimeters cubed (cells/mm^3)
Interval 10.0 to 1121.0
|
—
|
374 cells per millimeters cubed (cells/mm^3)
Interval 66.0 to 914.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Week 96, n=58, 62, 73, 50
|
417 cells per millimeters cubed (cells/mm^3)
Interval 82.0 to 744.0
|
567 cells per millimeters cubed (cells/mm^3)
Interval 82.0 to 1342.0
|
463 cells per millimeters cubed (cells/mm^3)
Interval 21.0 to 929.0
|
—
|
409 cells per millimeters cubed (cells/mm^3)
Interval 179.0 to 868.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Week 132, n=50, 56, 64, 47
|
386 cells per millimeters cubed (cells/mm^3)
Interval 38.0 to 820.0
|
642 cells per millimeters cubed (cells/mm^3)
Interval 159.0 to 1193.0
|
486 cells per millimeters cubed (cells/mm^3)
Interval 16.0 to 1769.0
|
—
|
395 cells per millimeters cubed (cells/mm^3)
Interval 120.0 to 1015.0
|
—
|
—
|
—
|
|
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Week 168, n=40, 47, 20, 39
|
409 cells per millimeters cubed (cells/mm^3)
Interval 59.0 to 1097.0
|
619 cells per millimeters cubed (cells/mm^3)
Interval 260.0 to 1312.0
|
460 cells per millimeters cubed (cells/mm^3)
Interval 51.0 to 890.0
|
—
|
513 cells per millimeters cubed (cells/mm^3)
Interval 133.0 to 1069.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously particpated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Outcome measures
| Measure |
NFV Population (APV30001)
n=18 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=221 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=54 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=119 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Baseline, n=119, 18, 221, 54
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.6
|
4.82 log 10 copies per milliliter
Interval 2.65 to 7.29
|
1.78 log 10 copies per milliliter
Interval 1.69 to 5.66
|
—
|
4.82 log 10 copies per milliliter
Interval 1.69 to 7.4
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 24, n=119, 17, 217, 51
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.7
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.49
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.34
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.8
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 48, n=118, 17, 218, 49
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.4
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.03
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.13
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.9
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 72, n=113, 15, 204, 46
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.5
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.83
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.34
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.8
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 96, n=106, 15, 192, 43
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.6
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.38
|
1.69 log 10 copies per milliliter
Interval 1.69 to 1.69
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.7
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 120, n=96, 15, 183, 40
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.1
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.53
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.6
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.9
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 144, n=89, 15, 173, 39
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.9
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.38
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.82
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.2
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 168, n=81, 14, 160, 38
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.0
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.44
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.27
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.8
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 180, n=82, 12, 159, 34
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.3
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.71
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.95
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.7
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 204, n=78, 12, 153, 27
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.5
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.26
|
1.69 log 10 copies per milliliter
Interval 1.69 to 2.91
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 3.8
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Week 216, n=80, 0, 143, 4
|
NA log 10 copies per milliliter
No participants were analyzed in this arm at this time point.
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.59
|
1.69 log 10 copies per milliliter
Interval 1.69 to 1.69
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed. The PI naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Outcome measures
| Measure |
NFV Population (APV30001)
n=78 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=93 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=82 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=73 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Week 72, n=65, 73, 80, 53
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.4
|
1.7 log 10 copies per milliliter
Interval 1.7 to 4.7
|
1.7 log 10 copies per milliliter
Interval 1.7 to 5.3
|
—
|
1.72 log 10 copies per milliliter
Interval 1.7 to 5.5
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Baseline, n=73, 78, 92, 82
|
4.06 log 10 copies per milliliter
Interval 2.3 to 5.9
|
1.7 log 10 copies per milliliter
Interval 1.7 to 4.9
|
1.81 log 10 copies per milliliter
Interval 1.7 to 6.2
|
—
|
3.96 log 10 copies per milliliter
Interval 3.0 to 5.8
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Week 12, n=69, 78, 92, 79
|
1.81 log 10 copies per milliliter
Interval 1.7 to 5.8
|
1.7 log 10 copies per milliliter
Interval 1.7 to 6.0
|
2.03 log 10 copies per milliliter
Interval 1.7 to 5.9
|
—
|
1.7 log 10 copies per milliliter
Interval 1.7 to 5.3
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Week 24, n=73, 75, 93, 79
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.6
|
1.7 log 10 copies per milliliter
Interval 1.7 to 5.5
|
1.9 log 10 copies per milliliter
Interval 1.7 to 5.7
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.8
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Week 48, n=73, 77, 85, 68
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.8
|
1.7 log 10 copies per milliliter
Interval 1.7 to 5.3
|
1.7 log 10 copies per milliliter
Interval 1.7 to 5.1
|
—
|
1.71 log 10 copies per milliliter
Interval 1.7 to 4.5
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Week 96, n=60, 62, 75, 51
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.2
|
1.7 log 10 copies per milliliter
Interval 1.7 to 5.4
|
1.7 log 10 copies per milliliter
Interval 1.7 to 5.8
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.9
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Week 132, n=50, 58, 65, 46
|
1.69 log 10 copies per milliliter
Interval 1.69 to 5.8
|
1.7 log 10 copies per milliliter
Interval 1.7 to 4.0
|
1.7 log 10 copies per milliliter
Interval 1.7 to 5.3
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.8
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Week 168, n=44, 48, 20, 39
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.9
|
1.7 log 10 copies per milliliter
Interval 1.7 to 2.8
|
1.7 log 10 copies per milliliter
Interval 1.7 to 4.5
|
—
|
1.69 log 10 copies per milliliter
Interval 1.69 to 4.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 180, 240, 300, 360, 420, and 432Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Outcome measures
| Measure |
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=101 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Week 180, n=14
|
—
|
—
|
—
|
—
|
1.7 log 10 copies per milliliters
Interval 1.7 to 4.1
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Week 240, n=101
|
—
|
—
|
—
|
—
|
1.7 log 10 copies per milliliters
Interval 1.7 to 4.4
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Week 300, n=82
|
—
|
—
|
—
|
—
|
1.7 log 10 copies per milliliters
Interval 1.7 to 4.5
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Week 360, n=53
|
—
|
—
|
—
|
—
|
1.7 log 10 copies per milliliters
Interval 1.7 to 4.6
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Week 420, n=52
|
—
|
—
|
—
|
—
|
1.7 log 10 copies per milliliters
Interval 1.7 to 4.9
|
—
|
—
|
—
|
|
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Week 432, n=41
|
—
|
—
|
—
|
—
|
1.7 log 10 copies per milliliters
Interval 1.7 to 4.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to 31 January 2006 (up to Week 264)Population: All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.
The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.
Outcome measures
| Measure |
NFV Population (APV30001)
n=18 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=221 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=54 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
n=73 Participants
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=119 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
n=78 Participants
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
n=104 Participants
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
n=86 Participants
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
CDC class A to CDC class C
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
CDC class B to CDC class C
|
0 participants
|
5 participants
|
3 participants
|
1 participants
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
CDC class C to new CDC class C
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
CDC class A, B, or C to death (on treatment)
|
0 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to 31 January 2006 (up to Week 264)Population: All participants receiving FPV or NFV in Studies APV30001 and APV30002.
The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.
Outcome measures
| Measure |
NFV Population (APV30001)
n=18 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=221 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=54 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=119 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Candidiasis, oropharyngeal
|
0 participants
|
7 participants
|
0 participants
|
—
|
4 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Herpes zoster
|
0 participants
|
3 participants
|
3 participants
|
—
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Diarrhea lasting >1 month
|
0 participants
|
1 participants
|
2 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Candidiasis, vulvovaginal
|
0 participants
|
0 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Cervical dysplasia
|
0 participants
|
0 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Fever lasting >1 month
|
0 participants
|
0 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Hairy leukoplakia, oral
|
0 participants
|
1 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Peripheral neuropathy
|
0 participants
|
2 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Cytomegalovirus retinitis
|
0 participants
|
0 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Herpes simplex
|
0 participants
|
1 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Mycobacterium tuberculosis, any site
|
0 participants
|
2 participants
|
1 participants
|
—
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Encepathopathy, HIV-related
|
0 participants
|
1 participants
|
0 participants
|
—
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Kaposis's sarcoma, cutaneous
|
0 participants
|
1 participants
|
0 participants
|
—
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Lymphoma,immunoblastic
|
0 participants
|
1 participants
|
0 participants
|
—
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Mycobacterium avium complex/ M kansaii
|
0 participants
|
1 participants
|
0 participants
|
—
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Pneumocystis carinii pneumonia
|
0 participants
|
1 participants
|
0 participants
|
—
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Progressive multifocal leukoencephalopathy
|
0 participants
|
1 participants
|
0 participants
|
—
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Toxoplasmosis of brain
|
0 participants
|
0 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Non-CDC HIV-associated conditions
|
0 participants
|
8 participants
|
0 participants
|
—
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to 31 January 2006 (up to Week 264)Population: All participants receiving FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.
The number of participants with the indicated HIV-associated conditions were assessed.
Outcome measures
| Measure |
NFV Population (APV30001)
n=78 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=104 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=86 Participants
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV Population (APV30001)
n=73 Participants
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Candidiasis, oropharyngeal
|
0 participants
|
0 participants
|
0 participants
|
—
|
5 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Hairy leukoplakia, oral
|
0 participants
|
0 participants
|
1 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Peripheral neuropathy
|
1 participants
|
0 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Diarrhea lasting >1 month
|
1 participants
|
0 participants
|
0 participants
|
—
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Herpes Zoster
|
0 participants
|
1 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Mycobacterium tuberculosis, any site
|
0 participants
|
0 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Other, Non-CDC HIV associated condition
|
0 participants
|
1 participants
|
0 participants
|
—
|
1 participants
|
—
|
—
|
—
|
Adverse Events
FPV Population (APV30001)
Serious events: 33 serious events
Other events: 115 other events
Deaths: 0 deaths
NFV Population (APV30001)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
FPV Population (APV30002)
Serious events: 62 serious events
Other events: 209 other events
Deaths: 0 deaths
NFV Population (APV30002)
Serious events: 7 serious events
Other events: 53 other events
Deaths: 0 deaths
FPV/RTV QD Population (APV30003)
Serious events: 20 serious events
Other events: 68 other events
Deaths: 0 deaths
FPV/RTV BID Population (APV30003)
Serious events: 14 serious events
Other events: 73 other events
Deaths: 0 deaths
PI-Naïve Population (Other Studies)
Serious events: 7 serious events
Other events: 76 other events
Deaths: 0 deaths
PI-Experienced Population (Other Studies)
Serious events: 13 serious events
Other events: 40 other events
Deaths: 0 deaths
Final Analysis Population (APV30005)
Serious events: 15 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FPV Population (APV30001)
n=119 participants at risk
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
NFV Population (APV30001)
n=18 participants at risk
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=221 participants at risk
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=54 participants at risk
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
n=73 participants at risk
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV/RTV BID Population (APV30003)
n=78 participants at risk
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
n=104 participants at risk
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
n=86 participants at risk
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
Final Analysis Population (APV30005)
n=111 participants at risk
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Abscess limb
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Meningitis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Leishmaniasis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Visceral leishmaniasis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Infections and infestations
Malaria
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Immune system disorders
Drug hypersensitivity
|
9.2%
11/119
|
0.00%
0/18
|
7.2%
16/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
2/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.84%
1/119
|
0.00%
0/18
|
1.8%
4/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
—
0/0
|
0.00%
0/111
|
|
Psychiatric disorders
Bipolar disorder
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Psychiatric disorders
Depression
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
1.9%
1/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Psychiatric disorders
Suicide attempt
|
0.84%
1/119
|
0.00%
0/18
|
0.45%
1/221
|
1.9%
1/54
|
2.7%
2/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Cardiac disorders
Cardiomegaly
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Cardiac disorders
Coronary artery disease
|
0.84%
1/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Investigations
Alanine aminotransferase increased
|
0.84%
1/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Investigations
Aspartate aminotransferase increased
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Investigations
Electrocardiogram abnormal
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Investigations
Lipase increased
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Investigations
Liver function test abnormal
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
General disorders
Chest pain
|
0.84%
1/119
|
0.00%
0/18
|
2.3%
5/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
General disorders
Chest discomfort
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
General disorders
Feeling hot
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
General disorders
Pyrexia
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
General disorders
Malaise
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/119
|
5.6%
1/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Nervous system disorders
Paralysis
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Nervous system disorders
Headache
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Nervous system disorders
Convulsion
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Nervous system disorders
Dizziness
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Superinfection lung
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Enterocolitis infectious
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Gastroenteritis
|
0.84%
1/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Herpes simplex
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Orchitis
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Peritonsillar abscess
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Pneumonia
|
0.84%
1/119
|
0.00%
0/18
|
1.4%
3/221
|
0.00%
0/54
|
2.7%
2/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Scrotal abscess
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Sepsis
|
0.84%
1/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Syphilis
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Viral infection
|
0.84%
1/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Appendicitis
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Bronchitis
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Cellulitis
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Erysipelas
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Influenza
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Infections and infestations
Localised infection
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Anogenital warts
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Nervous system disorders
Syncope
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Reproductive system and breast disorders
Breast mass
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.84%
1/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Anal stenosis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
1.4%
1/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Vascular disorders
Hypertension
|
0.00%
0/119
|
0.00%
0/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Eye disorders
Pterygium
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/119
|
0.00%
0/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Metabolism and nutrition disorders
Hyperthyroidism
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Metabolism and nutrition disorders
Thyroiditis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
2.3%
2/86
|
0.90%
1/111
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/119
|
0.00%
0/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
Other adverse events
| Measure |
FPV Population (APV30001)
n=119 participants at risk
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
|
NFV Population (APV30001)
n=18 participants at risk
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
|
FPV Population (APV30002)
n=221 participants at risk
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
|
NFV Population (APV30002)
n=54 participants at risk
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
|
FPV/RTV QD Population (APV30003)
n=73 participants at risk
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
|
FPV/RTV BID Population (APV30003)
n=78 participants at risk
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
|
PI-Naïve Population (Other Studies)
n=104 participants at risk
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
|
PI-Experienced Population (Other Studies)
n=86 participants at risk
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
|
Final Analysis Population (APV30005)
n=111 participants at risk
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Paraesthesia oral
|
0.84%
1/119
|
0.00%
0/18
|
8.6%
19/221
|
0.00%
0/54
|
9.6%
7/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
4/119
|
0.00%
0/18
|
8.1%
18/221
|
1.9%
1/54
|
2.7%
2/73
|
3.8%
3/78
|
1.9%
2/104
|
2.3%
2/86
|
2.7%
3/111
|
|
Investigations
Blood triglycerides increased
|
1.7%
2/119
|
0.00%
0/18
|
7.7%
17/221
|
1.9%
1/54
|
4.1%
3/73
|
3.8%
3/78
|
1.9%
2/104
|
2.3%
2/86
|
0.00%
0/111
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
5/119
|
0.00%
0/18
|
6.8%
15/221
|
1.9%
1/54
|
0.00%
0/73
|
6.4%
5/78
|
0.96%
1/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Nervous system disorders
Hypoasthesia
|
2.5%
3/119
|
0.00%
0/18
|
6.3%
14/221
|
5.6%
3/54
|
4.1%
3/73
|
6.4%
5/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Sexual transmission of infection
|
0.00%
0/119
|
5.6%
1/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/119
|
0.00%
0/18
|
6.3%
14/221
|
9.3%
5/54
|
2.7%
2/73
|
0.00%
0/78
|
1.9%
2/104
|
0.00%
0/86
|
1.8%
2/111
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.5%
3/119
|
0.00%
0/18
|
5.4%
12/221
|
5.6%
3/54
|
6.8%
5/73
|
6.4%
5/78
|
1.9%
2/104
|
0.00%
0/86
|
2.7%
3/111
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/119
|
0.00%
0/18
|
5.9%
13/221
|
0.00%
0/54
|
2.7%
2/73
|
9.0%
7/78
|
1.9%
2/104
|
1.2%
1/86
|
1.8%
2/111
|
|
Investigations
Lipase increased
|
2.5%
3/119
|
0.00%
0/18
|
5.9%
13/221
|
0.00%
0/54
|
8.2%
6/73
|
2.6%
2/78
|
0.00%
0/104
|
3.5%
3/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
4/119
|
0.00%
0/18
|
5.9%
13/221
|
3.7%
2/54
|
12.3%
9/73
|
5.1%
4/78
|
1.9%
2/104
|
4.7%
4/86
|
10.8%
12/111
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.2%
5/119
|
0.00%
0/18
|
5.9%
13/221
|
1.9%
1/54
|
4.1%
3/73
|
1.3%
1/78
|
4.8%
5/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.7%
2/119
|
0.00%
0/18
|
5.4%
12/221
|
5.6%
3/54
|
4.1%
3/73
|
6.4%
5/78
|
0.96%
1/104
|
1.2%
1/86
|
1.8%
2/111
|
|
Respiratory, thoracic and mediastinal disorders
Seasonal allergy
|
4.2%
5/119
|
0.00%
0/18
|
5.4%
12/221
|
0.00%
0/54
|
2.7%
2/73
|
1.3%
1/78
|
1.9%
2/104
|
0.00%
0/86
|
1.8%
2/111
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
4/119
|
0.00%
0/18
|
4.5%
10/221
|
7.4%
4/54
|
5.5%
4/73
|
2.6%
2/78
|
0.00%
0/104
|
4.7%
4/86
|
0.00%
0/111
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/119
|
0.00%
0/18
|
3.2%
7/221
|
7.4%
4/54
|
9.6%
7/73
|
6.4%
5/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Infections and infestations
Ear infection
|
1.7%
2/119
|
0.00%
0/18
|
0.00%
0/221
|
5.6%
3/54
|
4.1%
3/73
|
1.3%
1/78
|
0.96%
1/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Infections and infestations
Syphilis
|
4.2%
5/119
|
0.00%
0/18
|
2.3%
5/221
|
5.6%
3/54
|
1.4%
1/73
|
1.3%
1/78
|
3.8%
4/104
|
2.3%
2/86
|
0.00%
0/111
|
|
Infections and infestations
Tonsillitis
|
4.2%
5/119
|
0.00%
0/18
|
2.7%
6/221
|
5.6%
3/54
|
0.00%
0/73
|
1.3%
1/78
|
0.96%
1/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Infections and infestations
Viral infection
|
0.84%
1/119
|
0.00%
0/18
|
3.2%
7/221
|
5.6%
3/54
|
1.4%
1/73
|
1.3%
1/78
|
3.8%
4/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Skin and subcutaneous tissue disorders
Skin papilloma
|
0.00%
0/119
|
0.00%
0/18
|
2.3%
5/221
|
1.9%
1/54
|
13.7%
10/73
|
5.1%
4/78
|
0.96%
1/104
|
2.3%
2/86
|
0.90%
1/111
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.5%
3/119
|
0.00%
0/18
|
4.1%
9/221
|
1.9%
1/54
|
8.2%
6/73
|
7.7%
6/78
|
1.9%
2/104
|
2.3%
2/86
|
0.00%
0/111
|
|
Ear and labyrinth disorders
Vertigo
|
0.84%
1/119
|
0.00%
0/18
|
1.8%
4/221
|
0.00%
0/54
|
4.1%
3/73
|
9.0%
7/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
2/119
|
0.00%
0/18
|
2.3%
5/221
|
0.00%
0/54
|
6.8%
5/73
|
3.8%
3/78
|
0.96%
1/104
|
2.3%
2/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
2/119
|
0.00%
0/18
|
2.7%
6/221
|
0.00%
0/54
|
4.1%
3/73
|
6.4%
5/78
|
4.8%
5/104
|
0.00%
0/86
|
0.90%
1/111
|
|
General disorders
Influenza like illness
|
1.7%
2/119
|
0.00%
0/18
|
2.7%
6/221
|
1.9%
1/54
|
4.1%
3/73
|
6.4%
5/78
|
0.00%
0/104
|
2.3%
2/86
|
0.00%
0/111
|
|
Infections and infestations
Tinea pedis
|
4.2%
5/119
|
0.00%
0/18
|
4.1%
9/221
|
3.7%
2/54
|
0.00%
0/73
|
2.6%
2/78
|
5.8%
6/104
|
0.00%
0/86
|
2.7%
3/111
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/119
|
0.00%
0/18
|
1.8%
4/221
|
3.7%
2/54
|
5.5%
4/73
|
3.8%
3/78
|
2.9%
3/104
|
0.00%
0/86
|
9.0%
10/111
|
|
Infections and infestations
Rhinitis
|
1.7%
2/119
|
0.00%
0/18
|
3.2%
7/221
|
3.7%
2/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
3.5%
3/86
|
6.3%
7/111
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
51/119
|
27.8%
5/18
|
59.3%
131/221
|
27.8%
15/54
|
37.0%
27/73
|
47.4%
37/78
|
15.4%
16/104
|
16.3%
14/86
|
12.6%
14/111
|
|
Gastrointestinal disorders
Nausea
|
39.5%
47/119
|
11.1%
2/18
|
45.2%
100/221
|
14.8%
8/54
|
28.8%
21/73
|
26.9%
21/78
|
8.7%
9/104
|
0.00%
0/86
|
6.3%
7/111
|
|
Infections and infestations
Upper respiratory tract infection
|
35.3%
42/119
|
22.2%
4/18
|
31.2%
69/221
|
55.6%
30/54
|
30.1%
22/73
|
24.4%
19/78
|
20.2%
21/104
|
9.3%
8/86
|
28.8%
32/111
|
|
Infections and infestations
Nasopharyngitis
|
32.8%
39/119
|
55.6%
10/18
|
21.7%
48/221
|
7.4%
4/54
|
16.4%
12/73
|
24.4%
19/78
|
15.4%
16/104
|
16.3%
14/86
|
20.7%
23/111
|
|
Skin and subcutaneous tissue disorders
Rash
|
29.4%
35/119
|
11.1%
2/18
|
18.6%
41/221
|
13.0%
7/54
|
11.0%
8/73
|
15.4%
12/78
|
3.8%
4/104
|
1.2%
1/86
|
6.3%
7/111
|
|
Nervous system disorders
Headache
|
28.6%
34/119
|
16.7%
3/18
|
26.7%
59/221
|
5.6%
3/54
|
19.2%
14/73
|
35.9%
28/78
|
9.6%
10/104
|
7.0%
6/86
|
8.1%
9/111
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.2%
24/119
|
0.00%
0/18
|
25.3%
56/221
|
24.1%
13/54
|
17.8%
13/73
|
16.7%
13/78
|
4.8%
5/104
|
7.0%
6/86
|
9.0%
10/111
|
|
General disorders
Fatigue
|
18.5%
22/119
|
5.6%
1/18
|
24.4%
54/221
|
7.4%
4/54
|
24.7%
18/73
|
21.8%
17/78
|
5.8%
6/104
|
4.7%
4/86
|
2.7%
3/111
|
|
Gastrointestinal disorders
Vomiting
|
16.8%
20/119
|
11.1%
2/18
|
24.0%
53/221
|
13.0%
7/54
|
23.3%
17/73
|
11.5%
9/78
|
3.8%
4/104
|
3.5%
3/86
|
3.6%
4/111
|
|
General disorders
Pyrexia
|
16.0%
19/119
|
0.00%
0/18
|
13.6%
30/221
|
5.6%
3/54
|
11.0%
8/73
|
7.7%
6/78
|
5.8%
6/104
|
9.3%
8/86
|
0.90%
1/111
|
|
Psychiatric disorders
Depression
|
15.1%
18/119
|
0.00%
0/18
|
13.6%
30/221
|
11.1%
6/54
|
17.8%
13/73
|
23.1%
18/78
|
9.6%
10/104
|
10.5%
9/86
|
5.4%
6/111
|
|
Infections and infestations
Sinusitis
|
13.4%
16/119
|
11.1%
2/18
|
10.4%
23/221
|
9.3%
5/54
|
8.2%
6/73
|
14.1%
11/78
|
6.7%
7/104
|
9.3%
8/86
|
1.8%
2/111
|
|
Infections and infestations
Bronchitis
|
12.6%
15/119
|
0.00%
0/18
|
18.1%
40/221
|
16.7%
9/54
|
17.8%
13/73
|
10.3%
8/78
|
8.7%
9/104
|
11.6%
10/86
|
7.2%
8/111
|
|
Psychiatric disorders
Insomnia
|
12.6%
15/119
|
0.00%
0/18
|
14.5%
32/221
|
9.3%
5/54
|
17.8%
13/73
|
19.2%
15/78
|
8.7%
9/104
|
4.7%
4/86
|
3.6%
4/111
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
14/119
|
0.00%
0/18
|
13.1%
29/221
|
13.0%
7/54
|
15.1%
11/73
|
14.1%
11/78
|
4.8%
5/104
|
2.3%
2/86
|
8.1%
9/111
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
14/119
|
0.00%
0/18
|
7.7%
17/221
|
9.3%
5/54
|
13.7%
10/73
|
9.0%
7/78
|
4.8%
5/104
|
3.5%
3/86
|
6.3%
7/111
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.8%
14/119
|
5.6%
1/18
|
8.1%
18/221
|
0.00%
0/54
|
6.8%
5/73
|
11.5%
9/78
|
2.9%
3/104
|
7.0%
6/86
|
0.00%
0/111
|
|
Infections and infestations
Anogenital warts
|
10.9%
13/119
|
0.00%
0/18
|
2.3%
5/221
|
3.7%
2/54
|
12.3%
9/73
|
1.3%
1/78
|
3.8%
4/104
|
3.5%
3/86
|
0.90%
1/111
|
|
Nervous system disorders
Dizziness
|
10.9%
13/119
|
11.1%
2/18
|
11.3%
25/221
|
0.00%
0/54
|
4.1%
3/73
|
11.5%
9/78
|
0.96%
1/104
|
4.7%
4/86
|
0.90%
1/111
|
|
Infections and infestations
Gastroenteritis
|
10.9%
13/119
|
11.1%
2/18
|
6.3%
14/221
|
14.8%
8/54
|
9.6%
7/73
|
6.4%
5/78
|
5.8%
6/104
|
3.5%
3/86
|
3.6%
4/111
|
|
Infections and infestations
Influenza
|
10.9%
13/119
|
0.00%
0/18
|
16.7%
37/221
|
13.0%
7/54
|
16.4%
12/73
|
10.3%
8/78
|
8.7%
9/104
|
7.0%
6/86
|
10.8%
12/111
|
|
Infections and infestations
Herpes simplex
|
10.1%
12/119
|
0.00%
0/18
|
13.6%
30/221
|
7.4%
4/54
|
0.00%
0/73
|
2.6%
2/78
|
0.96%
1/104
|
2.3%
2/86
|
3.6%
4/111
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
11/119
|
11.1%
2/18
|
16.7%
37/221
|
14.8%
8/54
|
19.2%
14/73
|
21.8%
17/78
|
8.7%
9/104
|
10.5%
9/86
|
6.3%
7/111
|
|
Gastrointestinal disorders
Abdominal pain
|
8.4%
10/119
|
0.00%
0/18
|
14.5%
32/221
|
5.6%
3/54
|
12.3%
9/73
|
16.7%
13/78
|
0.96%
1/104
|
5.8%
5/86
|
3.6%
4/111
|
|
Infections and infestations
Pharyngitis
|
8.4%
10/119
|
11.1%
2/18
|
6.3%
14/221
|
7.4%
4/54
|
9.6%
7/73
|
6.4%
5/78
|
0.96%
1/104
|
3.5%
3/86
|
4.5%
5/111
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.4%
10/119
|
5.6%
1/18
|
8.1%
18/221
|
7.4%
4/54
|
15.1%
11/73
|
9.0%
7/78
|
0.96%
1/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.6%
9/119
|
0.00%
0/18
|
3.2%
7/221
|
1.9%
1/54
|
0.00%
0/73
|
5.1%
4/78
|
0.96%
1/104
|
2.3%
2/86
|
0.00%
0/111
|
|
Psychiatric disorders
Anxiety
|
6.7%
8/119
|
0.00%
0/18
|
9.5%
21/221
|
5.6%
3/54
|
15.1%
11/73
|
15.4%
12/78
|
3.8%
4/104
|
2.3%
2/86
|
1.8%
2/111
|
|
General disorders
Asthenia
|
6.7%
8/119
|
5.6%
1/18
|
5.0%
11/221
|
1.9%
1/54
|
4.1%
3/73
|
9.0%
7/78
|
2.9%
3/104
|
2.3%
2/86
|
0.00%
0/111
|
|
Vascular disorders
Hypertension
|
6.7%
8/119
|
0.00%
0/18
|
9.0%
20/221
|
1.9%
1/54
|
4.1%
3/73
|
6.4%
5/78
|
4.8%
5/104
|
1.2%
1/86
|
9.9%
11/111
|
|
General disorders
Oedema peripheral
|
6.7%
8/119
|
0.00%
0/18
|
4.5%
10/221
|
3.7%
2/54
|
1.4%
1/73
|
3.8%
3/78
|
0.96%
1/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.7%
8/119
|
0.00%
0/18
|
5.4%
12/221
|
11.1%
6/54
|
2.7%
2/73
|
2.6%
2/78
|
1.9%
2/104
|
2.3%
2/86
|
8.1%
9/111
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
7/119
|
0.00%
0/18
|
9.0%
20/221
|
5.6%
3/54
|
9.6%
7/73
|
5.1%
4/78
|
0.96%
1/104
|
4.7%
4/86
|
2.7%
3/111
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
7/119
|
0.00%
0/18
|
4.1%
9/221
|
1.9%
1/54
|
4.1%
3/73
|
2.6%
2/78
|
5.8%
6/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
7/119
|
5.6%
1/18
|
7.2%
16/221
|
0.00%
0/54
|
11.0%
8/73
|
7.7%
6/78
|
4.8%
5/104
|
4.7%
4/86
|
1.8%
2/111
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
|
5.9%
7/119
|
0.00%
0/18
|
4.1%
9/221
|
0.00%
0/54
|
2.7%
2/73
|
1.3%
1/78
|
1.9%
2/104
|
3.5%
3/86
|
0.90%
1/111
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.9%
7/119
|
0.00%
0/18
|
5.0%
11/221
|
1.9%
1/54
|
5.5%
4/73
|
5.1%
4/78
|
0.96%
1/104
|
2.3%
2/86
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
7/119
|
0.00%
0/18
|
0.90%
2/221
|
3.7%
2/54
|
1.4%
1/73
|
1.3%
1/78
|
0.96%
1/104
|
1.2%
1/86
|
0.00%
0/111
|
|
General disorders
Chest discomfort
|
5.0%
6/119
|
0.00%
0/18
|
1.8%
4/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Skin and subcutaneous tissue disorders
Dermititis
|
5.0%
6/119
|
0.00%
0/18
|
2.7%
6/221
|
0.00%
0/54
|
2.7%
2/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
6/119
|
0.00%
0/18
|
8.1%
18/221
|
1.9%
1/54
|
4.1%
3/73
|
9.0%
7/78
|
0.00%
0/104
|
2.3%
2/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
6/119
|
5.6%
1/18
|
3.6%
8/221
|
0.00%
0/54
|
9.6%
7/73
|
3.8%
3/78
|
0.96%
1/104
|
0.00%
0/86
|
2.7%
3/111
|
|
Nervous system disorders
Paraesthesia
|
5.0%
6/119
|
5.6%
1/18
|
4.5%
10/221
|
0.00%
0/54
|
11.0%
8/73
|
7.7%
6/78
|
0.00%
0/104
|
2.3%
2/86
|
0.90%
1/111
|
|
Infections and infestations
Urinary tract infection
|
5.0%
6/119
|
0.00%
0/18
|
5.0%
11/221
|
11.1%
6/54
|
4.1%
3/73
|
1.3%
1/78
|
0.96%
1/104
|
1.2%
1/86
|
6.3%
7/111
|
|
General disorders
Dental caries
|
0.00%
0/119
|
11.1%
2/18
|
0.45%
1/221
|
1.9%
1/54
|
1.4%
1/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
1.8%
2/111
|
|
Infections and infestations
Pneumonia
|
3.4%
4/119
|
11.1%
2/18
|
0.90%
2/221
|
5.6%
3/54
|
4.1%
3/73
|
2.6%
2/78
|
0.00%
0/104
|
3.5%
3/86
|
1.8%
2/111
|
|
Infections and infestations
Vaginal infection
|
1.7%
2/119
|
11.1%
2/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
1.2%
1/86
|
0.00%
0/111
|
|
Infections and infestations
Abscess limb
|
3.4%
4/119
|
5.6%
1/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.7%
2/119
|
5.6%
1/18
|
2.7%
6/221
|
3.7%
2/54
|
1.4%
1/73
|
1.3%
1/78
|
0.96%
1/104
|
0.00%
0/86
|
1.8%
2/111
|
|
Infections and infestations
Bronchopneumonia
|
0.84%
1/119
|
5.6%
1/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Burns second degree
|
0.00%
0/119
|
5.6%
1/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Cellulitis
|
3.4%
4/119
|
5.6%
1/18
|
1.8%
4/221
|
3.7%
2/54
|
2.7%
2/73
|
1.3%
1/78
|
1.9%
2/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Eye disorders
Conjunctivitis
|
3.4%
4/119
|
5.6%
1/18
|
6.3%
14/221
|
3.7%
2/54
|
4.1%
3/73
|
9.0%
7/78
|
1.9%
2/104
|
3.5%
3/86
|
1.8%
2/111
|
|
Gastrointestinal disorders
Constipation
|
1.7%
2/119
|
5.6%
1/18
|
3.6%
8/221
|
5.6%
3/54
|
5.5%
4/73
|
5.1%
4/78
|
1.9%
2/104
|
4.7%
4/86
|
1.8%
2/111
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.2%
5/119
|
5.6%
1/18
|
2.3%
5/221
|
3.7%
2/54
|
1.4%
1/73
|
3.8%
3/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.84%
1/119
|
5.6%
1/18
|
0.90%
2/221
|
3.7%
2/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Folliculitis
|
4.2%
5/119
|
5.6%
1/18
|
6.3%
14/221
|
7.4%
4/54
|
1.4%
1/73
|
0.00%
0/78
|
2.9%
3/104
|
3.5%
3/86
|
0.90%
1/111
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
5/119
|
5.6%
1/18
|
0.90%
2/221
|
1.9%
1/54
|
4.1%
3/73
|
1.3%
1/78
|
1.9%
2/104
|
1.2%
1/86
|
3.6%
4/111
|
|
Vascular disorders
Hot flush
|
0.00%
0/119
|
5.6%
1/18
|
1.8%
4/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
1.9%
2/104
|
0.00%
0/86
|
1.8%
2/111
|
|
Musculoskeletal and connective tissue disorders
Joint sprain
|
1.7%
2/119
|
5.6%
1/18
|
1.8%
4/221
|
1.9%
1/54
|
2.7%
2/73
|
0.00%
0/78
|
1.9%
2/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.4%
4/119
|
5.6%
1/18
|
7.2%
16/221
|
1.9%
1/54
|
4.1%
3/73
|
6.4%
5/78
|
0.00%
0/104
|
3.5%
3/86
|
0.00%
0/111
|
|
Infections and infestations
Parasitic infection intestinal
|
0.00%
0/119
|
5.6%
1/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Gastrointestinal disorders
Pelvic inflammatory disease
|
3.4%
4/119
|
5.6%
1/18
|
1.4%
3/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.90%
1/111
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/119
|
5.6%
1/18
|
0.90%
2/221
|
0.00%
0/54
|
0.00%
0/73
|
1.3%
1/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.84%
1/119
|
5.6%
1/18
|
0.00%
0/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Vaginal candidiasis
|
0.00%
0/119
|
5.6%
1/18
|
2.7%
6/221
|
1.9%
1/54
|
0.00%
0/73
|
0.00%
0/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Eye disorders
Vision blurred
|
0.00%
0/119
|
5.6%
1/18
|
2.3%
5/221
|
1.9%
1/54
|
1.4%
1/73
|
3.8%
3/78
|
0.96%
1/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
1.7%
2/119
|
5.6%
1/18
|
0.45%
1/221
|
0.00%
0/54
|
0.00%
0/73
|
0.00%
0/78
|
0.00%
0/104
|
0.00%
0/86
|
0.00%
0/111
|
|
Investigations
Weight decreased
|
4.2%
5/119
|
5.6%
1/18
|
8.1%
18/221
|
13.0%
7/54
|
4.1%
3/73
|
7.7%
6/78
|
3.8%
4/104
|
1.2%
1/86
|
6.3%
7/111
|
|
General disorders
Chest pain
|
4.2%
5/119
|
0.00%
0/18
|
8.6%
19/221
|
9.3%
5/54
|
4.1%
3/73
|
6.4%
5/78
|
3.8%
4/104
|
1.2%
1/86
|
2.7%
3/111
|
Additional Information
GSK Response Center
ViiV Healthcare
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER