Trial Outcomes & Findings for Antiretroviral Therapy (ART) Alone or With Delayed Chemo Versus ART With Immediate Chemo for Limited AIDS-related Kaposi's Sarcoma (NCT NCT01352117)
NCT ID: NCT01352117
Last Updated: 2019-11-14
Results Overview
KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS progression (PD), initiation of an alternate KS treatment, or no follow-up at Week 48 including death and missed visit), E2 (Stable: in follow-up at Week 48 with no KS PD nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 48, with KS partial or complete response (PR or CR) and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PR, stable, PR, CR) compared to study entry was evaluated at Week 48 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and dea
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
Entry through Week 48.
Results posted on
2019-11-14
Participant Flow
Participants were recruited from November 2011 to February 2016 at 10 sites in Africa and South America.
Participant milestones
| Measure |
Arm A: ART Alone or With Delayed ET
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
96
|
|
Overall Study
Entered Step 2 to Initiate Delayed ET
|
32
|
0
|
|
Overall Study
Study Week 48 Data Potential
|
80
|
83
|
|
Overall Study
Study Week 96 Data Potential
|
58
|
61
|
|
Overall Study
COMPLETED
|
75
|
72
|
|
Overall Study
NOT COMPLETED
|
21
|
24
|
Reasons for withdrawal
| Measure |
Arm A: ART Alone or With Delayed ET
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Overall Study
Death
|
15
|
16
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
|
Overall Study
Non-adherent to study requirements
|
1
|
1
|
|
Overall Study
Did not initiate study treatment
|
1
|
0
|
|
Overall Study
Ineligible (no KS diagnosis)
|
1
|
0
|
Baseline Characteristics
Antiretroviral Therapy (ART) Alone or With Delayed Chemo Versus ART With Immediate Chemo for Limited AIDS-related Kaposi's Sarcoma
Baseline characteristics by cohort
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=99 Participants
|
35 years
n=107 Participants
|
34 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
Malawi
|
30 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
Uganda
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Region of Enrollment
Zimbabwe
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
Kenya
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
Peru
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
89 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Other
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
HIV-1 RNA
|
5.11 log10 copies/mL
n=99 Participants
|
5.10 log10 copies/mL
n=107 Participants
|
5.11 log10 copies/mL
n=206 Participants
|
|
CD4 cell count, continuous
|
190 cells/mm^3
n=99 Participants
|
165 cells/mm^3
n=107 Participants
|
184 cells/mm^3
n=206 Participants
|
|
CD4 cell count, categorized
<200 cells/mm^3
|
50 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
CD4 cell count, categorized
>=200 cells/mm^3
|
44 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Karnofsky score
60
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Karnofsky score
70
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Karnofsky score
80
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Karnofsky score
90
|
54 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Karnofsky score
100
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
KS stage
KS tumor Stage T0
|
35 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
KS stage
KS tumor Stage T1
|
59 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
ART experience
ART-experienced
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
ART experience
ART-naive
|
94 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
189 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Entry through Week 48.Population: All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the Data and Safety Monitoring Board's \[DSMB\] recommendation to close the study became public).
KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS progression (PD), initiation of an alternate KS treatment, or no follow-up at Week 48 including death and missed visit), E2 (Stable: in follow-up at Week 48 with no KS PD nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 48, with KS partial or complete response (PR or CR) and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PR, stable, PR, CR) compared to study entry was evaluated at Week 48 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and dea
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=80 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=83 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry
E1 (Failure)
|
43 Participants
|
47 Participants
|
|
Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry
E2 (Stable)
|
13 Participants
|
9 Participants
|
|
Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry
E3 (Response)
|
24 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Entry and Week 48Population: All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.
KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=58 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=43 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
KS Progressive Disease at Week 48 Compared to Study Entry
KS PD at Week 48
|
21 Participants
|
7 Participants
|
|
KS Progressive Disease at Week 48 Compared to Study Entry
No KS PD at Week 48
|
37 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Entry and Week 48Population: All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.
KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=58 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=43 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
KS Partial Response at Week 48 Compared to Study Entry
KS PR at Week 48
|
21 Participants
|
23 Participants
|
|
KS Partial Response at Week 48 Compared to Study Entry
No KS PR at Week 48
|
37 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Entry and Week 48Population: All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.
KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=58 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=43 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
KS Complete Response at Week 48 Compared to Study Entry
No KS CR at Week 48
|
55 Participants
|
39 Participants
|
|
KS Complete Response at Week 48 Compared to Study Entry
KS CR at Week 48
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Entry and Week 48Population: All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.
KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=58 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=43 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
KS Partial or Complete Response at Week 48 Compared to Study Entry
Week 48: KS PR or CR
|
24 Participants
|
27 Participants
|
|
KS Partial or Complete Response at Week 48 Compared to Study Entry
Week 48: no KS PR or CR
|
34 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Entry through Week 48Population: All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public).
Premature study discontinuation by Week 48 due to any reason, including death.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=80 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=83 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Premature Study Discontinuation by Week 48
Premature study discontinuation by Week 48
|
13 Participants
|
11 Participants
|
|
Premature Study Discontinuation by Week 48
No premature study discontinuation by Week 48
|
67 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Entry through Week 96.Population: All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).
KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS PD, initiation of an alternate KS treatment, or no follow-up at Week 96 including death and missed visit), E2 (Stable: in follow-up at Week 96 with no KS progression nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 96, with KS PR or CR and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PD, stable, PR or CR) compared to study entry was evaluated at Week 96 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and deaths are from entry through Week 96.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=58 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=61 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry
E1 (Failure)
|
33 Participants
|
33 Participants
|
|
Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry
E2 (Stable)
|
4 Participants
|
0 Participants
|
|
Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry
E3 (Response)
|
21 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Entry and Week 96Population: All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.
KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=35 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=30 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
KS Progressive Disease at Week 96 Compared to Study Entry
KS PD at Week 96
|
10 Participants
|
2 Participants
|
|
KS Progressive Disease at Week 96 Compared to Study Entry
No KS PD at Week 96
|
25 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Entry and Week 96Population: All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.
KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=35 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=30 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
KS Partial Response at Week 96 Compared to Study Entry
No KS PR at Week 96
|
16 Participants
|
6 Participants
|
|
KS Partial Response at Week 96 Compared to Study Entry
KS PR at Week 96
|
19 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Entry and Week 96Population: All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.
KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=35 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=30 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
KS Complete Response at Week 96 Compared to Study Entry
KS CR at Week 96
|
2 Participants
|
4 Participants
|
|
KS Complete Response at Week 96 Compared to Study Entry
No KS CR at Week 96
|
33 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Entry and Week 96Population: All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.
KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=35 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=30 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
KS Partial or Complete Response at Week 96 Compared to Study Entry
KS PR or CR at Week 96
|
21 Participants
|
28 Participants
|
|
KS Partial or Complete Response at Week 96 Compared to Study Entry
No KS PR or CR at Week 96
|
14 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Entry through Week 96Population: All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).
Premature study discontinuation by Week 96 due to any reason, including death.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=58 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=61 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Premature Study Discontinuation by Week 96
Premature study discontinuation by Week 96
|
14 Participants
|
10 Participants
|
|
Premature Study Discontinuation by Week 96
No premature study discontinuation by Week 96
|
44 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: From entry through 96 weeksPopulation: All eligible participants who initiated study treatment.
KS progressive disease (PD) compared to study entry or best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Cumulative Incidence of Initial KS Progressive Disease by Week 96
|
60.61 cumulative events per 100 participants
Interval 48.98 to 70.38
|
52.73 cumulative events per 100 participants
Interval 40.17 to 63.82
|
SECONDARY outcome
Timeframe: From entry through 96 weeksPopulation: All eligible participants who initiated study treatment.
KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of delayed KS treatment (alternate KS treatment or delayed ET in Arm A) as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Cumulative Incidence of Initial KS Partial or Complete Response by Week 96
|
39.89 cumulative events per 100 participants
Interval 24.88 to 54.48
|
64.08 cumulative events per 100 participants
Interval 51.78 to 74.01
|
SECONDARY outcome
Timeframe: From study treatment initiation to 96 weeksPopulation: Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.
KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as "PR and CR combined and separately" to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS complete response, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on PR separately was withdrawn.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study treatment initiation to 96 weeksPopulation: Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.
KS complete response (CR) compared to study entry based on clinical evaluation of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as "PR and CR combined and separately" to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS CR, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on CR separately was withdrawn.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study treatment dispensation through up to Week 96, until long-term follow-up began in Step 3 or until study discontinuation.Population: All eligible participants who initiated study treatment.
Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
|
47 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: From study entry to Week 12Population: All eligible participants who initiated study treatment.
KS-IRIS was defined as KS progressive disease that occurs within 12 weeks of initiation of ART that is associated with an increase in peripheral blood CD4+ lymphocyte cell count of at least 50 cells/mm\^3 above the study screening value and/or a decrease in the HIV RNA level by at least 0.5 log10 below the study entry value prior to, or at the time of, documented KS progressive disease. Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored (1) when lost to follow-up, (2) at the study visit following Week 12 or (3) on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. Time of KS-IRIS was defined as the time of the initial KS progressive disease.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Cumulative Incidence of KS-IRIS
|
23.14 cumulative events per 100 participants
Interval 15.03 to 32.29
|
7.40 cumulative events per 100 participants
Interval 3.24 to 13.85
|
SECONDARY outcome
Timeframe: From ET dispensation to ET discontinuation (total duration of ET was up to 16 weeks)Population: All eligible participants who initiated study treatment. Arm A participants are limited to those who entered Step 2 to initiate delayed ET.
Etoposide (ET) was administered for a maximum of 8 cycles (16 weeks) from study entry (Arm B) or from Step 2 entry (Arm A). Dose modifications were reported as temporarily held, resumed at a different dose, deferred, prematurely discontinued and underdosed. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=32 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Percentage of Participants With Etoposide Dose Modification
Temporarily held
|
0 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants With Etoposide Dose Modification
Resumed at a different dose
|
15.6 percentage of participants
|
9.4 percentage of participants
|
|
Percentage of Participants With Etoposide Dose Modification
Deferred
|
37.5 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants With Etoposide Dose Modification
Discontinued
|
6.3 percentage of participants
|
10.4 percentage of participants
|
|
Percentage of Participants With Etoposide Dose Modification
Underdosed
|
0 percentage of participants
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.Population: All eligible participants who initiated study treatment and had HIV-1 RNA results available at the specific visit. HIV-1 RNA testing was done locally using Abbott RealTime HIV-1 Test or Roche AmpliPrep/Taqman HIV-1 Test. Only Arm A participants could enter Step 2 to initiate delayed ET.
HIV-1 RNA suppression was defined as plasma HIV-1 RNA \<400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA Suppression
Entry: HIV-1 RNA suppression
|
4.3 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA Suppression
Week 12: HIV-1 RNA suppression
|
90.3 percentage of participants
|
90.6 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA Suppression
Week 24: HIV-1 RNA suppression
|
94.5 percentage of participants
|
97.5 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA Suppression
Week 32: HIV-1 RNA suppression
|
92.0 percentage of participants
|
94.7 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA Suppression
Week 48: HIV-1 RNA suppression
|
95.3 percentage of participants
|
98.6 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA Suppression
Week 72: HIV-1 RNA suppression
|
91.2 percentage of participants
|
96.6 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA Suppression
Week 96: HIV-1 RNA suppression
|
92.9 percentage of participants
|
93.8 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA Suppression
Step 2 entry: HIV-1 RNA suppression
|
93.3 percentage of participants
|
—
|
|
Percentage of Participants With HIV-1 RNA Suppression
Step 2 Week 12: HIV-1 RNA suppression
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With HIV-1 RNA Suppression
Step 2 Week 24: HIV-1 RNA suppression
|
95.8 percentage of participants
|
—
|
|
Percentage of Participants With HIV-1 RNA Suppression
Step 2 Week 32: HIV-1 RNA suppression
|
96.0 percentage of participants
|
—
|
|
Percentage of Participants With HIV-1 RNA Suppression
Step 2 Week 48: HIV-1 RNA suppression
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With HIV-1 RNA Suppression
Step 2 Week 72: HIV-1 RNA suppression
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From treatment dispensation to Week 96Population: All eligible participants who initiated study treatment.
ARV dose modifications were reported as temporarily held, prematurely discontinued and increased. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Percentage of Participants With ARV Dose Modification
Temporarily held
|
7.4 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants With ARV Dose Modification
Prematurely discontinued
|
26.6 percentage of participants
|
21.9 percentage of participants
|
|
Percentage of Participants With ARV Dose Modification
Increased
|
1.1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.Population: At the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. Therefore, this outcome measure could not be analyzed.
Absolute change in log10 HIV-1 RNA from entry at study visits calculated as value at a given time point minus value at entry. This outcome was initially specified in the study protocol. However, at the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. It would be misleading to calculate change from entry to HIV RNA-1 levels that could not be quantified. Therefore, the data collected did not support the outcome and the analytic method initially proposed in the study protocol, and this outcome measure could not be analyzed. The SAP updated the HIV-1 RNA outcome measure to HIV-1 RNA suppression at study visits (please refer to the secondary outcome measure #20).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.Population: All eligible participants who initiated study treatment and had CD4 cell count results available at screening and the respective Step 1 visit or at Step 2 entry and the respective Step 2 visit.
Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 Participants
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Week 32: CD4 change
|
90 cells/mm^3
Interval 36.0 to 157.0
|
119 cells/mm^3
Interval 60.0 to 216.0
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Week 48: CD4 change
|
125 cells/mm^3
Interval 39.0 to 186.0
|
121 cells/mm^3
Interval 61.0 to 208.0
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Week 72: CD4 change
|
143 cells/mm^3
Interval 66.0 to 290.0
|
125 cells/mm^3
Interval 66.0 to 257.0
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Week 96: CD4 change
|
149 cells/mm^3
Interval 75.0 to 265.0
|
206 cells/mm^3
Interval 118.0 to 290.0
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Step 2 Week 12: CD4 change
|
-13 cells/mm^3
Interval -74.0 to 83.0
|
—
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Step 2 Week 24: CD4 change
|
-15 cells/mm^3
Interval -35.0 to 51.0
|
—
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Step 2 Week 32: CD4 change
|
28 cells/mm^3
Interval -7.0 to 71.0
|
—
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Step 2 Week 48: CD4 change
|
2 cells/mm^3
Interval -108.0 to 143.0
|
—
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Step 2 Week 72: CD4 change
|
51 cells/mm^3
Interval -97.0 to 131.0
|
—
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Week 12: CD4 change
|
40 cells/mm^3
Interval 12.0 to 118.0
|
67 cells/mm^3
Interval 5.0 to 114.0
|
|
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Week 24: CD4 change
|
57 cells/mm^3
Interval 3.0 to 139.0
|
121 cells/mm^3
Interval 47.0 to 210.0
|
SECONDARY outcome
Timeframe: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)Population: All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.
KS progressive disease (PD) compared to Step 2 entry (prior to initiation of delayed ET) or Step 2 best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=32 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A
|
35.78 cumulative events per 100 participants
Interval 17.74 to 54.28
|
—
|
SECONDARY outcome
Timeframe: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)Population: All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.
KS response, partial or complete (PR or CR) compared to Step 2 entry (prior to initiation of delayed ET) based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.
Outcome measures
| Measure |
Arm A: ART Alone or With Delayed ET
n=32 Participants
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A
|
62.57 cumulative events per 100 participants
Interval 31.65 to 82.6
|
—
|
Adverse Events
Arm A: ART Alone or With Delayed ET
Serious events: 34 serious events
Other events: 83 other events
Deaths: 15 deaths
Arm B: ART With Immediate ET
Serious events: 34 serious events
Other events: 88 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 participants at risk
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 participants at risk
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
4/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.1%
3/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.1%
2/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Death
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.1%
2/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Pyrexia
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.2%
4/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Bacterial sepsis
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Cellulitis
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.1%
2/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Disseminated cryptococcosis
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Disseminated tuberculosis
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Gastroenteritis
|
3.2%
3/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Malaria
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.1%
2/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Meningitis
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Meningitis bacterial
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Meningitis cryptococcal
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Parotitis
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pneumonia
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.2%
4/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pneumonia bacterial
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.1%
2/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pyelonephritis
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Salmonellosis
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Sepsis
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.1%
2/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Septic shock
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Sinusitis
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Tuberculosis
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.1%
2/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Transaminases increased
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Weight decreased
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
9.6%
9/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.2%
5/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Hyponatraemic seizure
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Renal and urinary disorders
Renal failure
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.1%
3/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Vascular disorders
Hypertension
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
Other adverse events
| Measure |
Arm A: ART Alone or With Delayed ET
n=94 participants at risk
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
|
Arm B: ART With Immediate ET
n=96 participants at risk
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.4%
7/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.2%
5/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.4%
6/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.2%
4/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
6/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.3%
8/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.2%
6/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
8/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
11.5%
11/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
4/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
9.4%
9/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
9/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
13.5%
13/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Chest pain
|
9.6%
9/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
10.4%
10/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Malaise
|
13.8%
13/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
10.4%
10/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Oedema peripheral
|
14.9%
14/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.2%
4/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Pain
|
5.3%
5/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.2%
4/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Peripheral swelling
|
7.4%
7/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.2%
5/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Pyrexia
|
26.6%
25/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
30.2%
29/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Bacteraemia
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.3%
8/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Bacterial sepsis
|
4.3%
4/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
7.3%
7/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Malaria
|
6.4%
6/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.2%
6/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pharyngitis
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
7.3%
7/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pneumonia bacterial
|
8.5%
8/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
7.3%
7/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pulmonary tuberculosis
|
3.2%
3/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.3%
8/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
18.8%
18/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
12.5%
12/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Alanine aminotransferase increased
|
9.6%
9/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
11.5%
11/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Aspartate aminotransferase increased
|
14.9%
14/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
18.8%
18/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood albumin decreased
|
36.2%
34/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
33.3%
32/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.6%
10/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.2%
6/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood bicarbonate decreased
|
16.0%
15/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
13.5%
13/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood creatinine increased
|
4.3%
4/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.2%
6/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood phosphorus decreased
|
6.4%
6/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.2%
6/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood potassium decreased
|
3.2%
3/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.2%
5/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood sodium decreased
|
41.5%
39/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
39.6%
38/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Haemoglobin decreased
|
25.5%
24/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
19.8%
19/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Neutrophil count decreased
|
34.0%
32/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
37.5%
36/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Platelet count decreased
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.2%
6/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Weight decreased
|
9.6%
9/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
11.5%
11/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
White blood cell count decreased
|
6.4%
6/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
7.3%
7/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
5/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
7.3%
7/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.0%
15/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
9.4%
9/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma
|
7.4%
7/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.1%
2/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
11.7%
11/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
14.6%
14/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Dizziness
|
5.3%
5/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.1%
3/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Headache
|
13.8%
13/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
13.5%
13/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Psychiatric disorders
Confusional state
|
5.3%
5/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.0%
1/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Renal and urinary disorders
Dysuria
|
2.1%
2/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
9.4%
9/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Renal and urinary disorders
Pollakiuria
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.2%
5/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.2%
5/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.3%
20/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
32.3%
31/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.8%
12/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.6%
15/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
5.3%
5/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.1%
2/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.1%
1/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
7.3%
7/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.2%
5/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.3%
4/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
7.3%
7/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/94 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.2%
5/96 • From study treatment dispensation to study completion at up to Week 240.
The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60