Trial Outcomes & Findings for Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome (NCT NCT00135356)
NCT ID: NCT00135356
Last Updated: 2010-05-07
Results Overview
Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
219 participants
Primary outcome timeframe
Baseline, Week 48
Results posted on
2010-05-07
Participant Flow
A total of 219 participants were enrolled and 18 were never randomized (1 poor/noncompliance; 10 no longer met study criteria; 5 withdrew consent). 201 participants were randomized; however, 1 participant was never treated and is not included in the participant flow.
Participant milestones
| Measure |
ATV/RTV Switch Arm
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
PI/RTV Control Arm
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
69
|
|
Overall Study
Discontinued Prior to Week 96 Visit
|
16
|
9
|
|
Overall Study
Discontinued on or After Week 96 Visit
|
1
|
0
|
|
Overall Study
COMPLETED
|
114
|
60
|
|
Overall Study
NOT COMPLETED
|
17
|
9
|
Reasons for withdrawal
| Measure |
ATV/RTV Switch Arm
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
PI/RTV Control Arm
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Surgery for abdominal fat
|
1
|
0
|
|
Overall Study
Change in antiviral regimen
|
0
|
1
|
|
Overall Study
Poor/noncompliance
|
1
|
1
|
|
Overall Study
No longer meets study criteria
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
Baseline Characteristics
Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
Baseline characteristics by cohort
| Measure |
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
43 Years
n=99 Participants
|
42 Years
n=107 Participants
|
43 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
83 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mestizo
|
31 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latino/Hispanic
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Europe
|
77 participants
n=99 Participants
|
39 participants
n=107 Participants
|
116 participants
n=206 Participants
|
|
Region of Enrollment
North America
|
54 participants
n=99 Participants
|
30 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Cluster of Differentiation 4 (CD4) Distribution
50 to <100 cells/mm3
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Cluster of Differentiation 4 (CD4) Distribution
100 to <200 cells/mm3
|
14 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Cluster of Differentiation 4 (CD4) Distribution
200 to <350 cells/mm3
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Cluster of Differentiation 4 (CD4) Distribution
350 to <500 cells/mm3
|
31 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Cluster of Differentiation 4 (CD4) Distribution
≥500 cells/mm3
|
60 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Cluster of Differentiation 4 (CD4) Distribution
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Fasting Glucose
<100 mg/dL
|
96 participants
n=99 Participants
|
49 participants
n=107 Participants
|
145 participants
n=206 Participants
|
|
Fasting Glucose
100 mg/dL to <126 mg/dL
|
23 participants
n=99 Participants
|
13 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Fasting Glucose
>=126 mg/dL
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Fasting Lipids
Triglycerides <150 mg/dL
|
29 participants
n=99 Participants
|
14 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Fasting Lipids
Triglycerides 150 mg/dL to <200 mg/dL
|
28 participants
n=99 Participants
|
9 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Fasting Lipids
Triglycerides 200 mg/dL to <500 mg/dL
|
52 participants
n=99 Participants
|
27 participants
n=107 Participants
|
79 participants
n=206 Participants
|
|
Fasting Lipids
Triglycerides >=500 mg/dL
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Fasting Lipids
Non-HDL Cholesterol <130 mg/dL
|
22 participants
n=99 Participants
|
16 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Fasting Lipids
Non-HDL Cholesterol 130 mg/dL to <160 mg/dL
|
31 participants
n=99 Participants
|
14 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Fasting Lipids
Non-HDL Cholesterol 160 mg/dL to <190 mg/dL
|
32 participants
n=99 Participants
|
15 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Fasting Lipids
Non-HDL Cholesterol 190 mg/dL to <220 mg/dL
|
22 participants
n=99 Participants
|
9 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Fasting Lipids
Non-HDL Cholesterol >=220 mg/dL
|
16 participants
n=99 Participants
|
8 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Fasting Lipids
LDL Cholesterol <100 mg/dL
|
40 participants
n=99 Participants
|
22 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
Fasting Lipids
LDL Cholesterol 100 mg/dL to <130 mg/dL
|
36 participants
n=99 Participants
|
25 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
Fasting Lipids
LDL Cholesterol 130 mg/dL to <160 mg/dL
|
30 participants
n=99 Participants
|
11 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Fasting Lipids
LDL Cholesterol 160 mg/dL to <190 mg/dL
|
11 participants
n=99 Participants
|
1 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Fasting Lipids
LDL Cholesterol >=190 mg/dL
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Fasting Lipids
Total Cholesterol <200 mg/dL
|
45 participants
n=99 Participants
|
28 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Fasting Lipids
Total Cholesterol 200 mg/dL to 240 mg/dL
|
42 participants
n=99 Participants
|
19 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
Fasting Lipids
Total Cholesterol 240 mg/dL to 300 mg/dL
|
29 participants
n=99 Participants
|
11 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Fasting Lipids
Total Cholesterol >=300 mg/dL
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Fasting Lipids
HDL Cholesterol <40 mg/dL
|
23 participants
n=99 Participants
|
21 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Fasting Lipids
HDL Cholesterol 40 mg/dL to <60 mg/dL
|
80 participants
n=99 Participants
|
32 participants
n=107 Participants
|
112 participants
n=206 Participants
|
|
Fasting Lipids
HDL Cholesterol >=60 mg/dL
|
20 participants
n=99 Participants
|
9 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA) Distribution
<50 c/mL
|
117 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
181 Participants
n=206 Participants
|
|
Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA) Distribution
50 to <400 c/mL
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA) Distribution
400 to <1000 c/mL
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA) Distribution
≥1000 c/mL
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Adipose Tissue at Baseline
VAT
|
131.9 cm2
n=99 Participants
|
128.1 cm2
n=107 Participants
|
129.4 cm2
n=206 Participants
|
|
Adipose Tissue at Baseline
SAT
|
209.5 cm2
n=99 Participants
|
183.9 cm2
n=107 Participants
|
193.6 cm2
n=206 Participants
|
|
Adipose Tissue at Baseline
TAT
|
356.2 cm2
n=99 Participants
|
328.6 cm2
n=107 Participants
|
352.0 cm2
n=206 Participants
|
|
Body Mass Index (BMI)
|
25.9 kg/m2
n=99 Participants
|
25.7 kg/m2
n=107 Participants
|
25.9 kg/m2
n=206 Participants
|
|
Body Weight
|
75 kg
n=99 Participants
|
77 kg
n=107 Participants
|
76 kg
n=206 Participants
|
|
CD4 Cell Count
|
470 cells/mm3
n=99 Participants
|
437 cells/mm3
n=107 Participants
|
459 cells/mm3
n=206 Participants
|
|
Trunk Fat, Limb Fat, Total Body Fat
Trunk Fat
|
11.8 kg
n=99 Participants
|
10.9 kg
n=107 Participants
|
11.4 kg
n=206 Participants
|
|
Trunk Fat, Limb Fat, Total Body Fat
Limb Fat
|
7.1 kg
n=99 Participants
|
6.7 kg
n=107 Participants
|
7.0 kg
n=206 Participants
|
|
Trunk Fat, Limb Fat, Total Body Fat
Total Body Fat
|
20.8 kg
n=99 Participants
|
18.7 kg
n=107 Participants
|
19.8 kg
n=206 Participants
|
|
Trunk-to-Limb Fat Ratio
|
1.59 ratio
n=99 Participants
|
1.73 ratio
n=107 Participants
|
1.62 ratio
n=206 Participants
|
|
Waist Circumference
|
94 cm
n=99 Participants
|
95 cm
n=107 Participants
|
94 cm
n=206 Participants
|
|
Waist-to-Hip Ratio
|
0.99 ratio
n=99 Participants
|
0.97 ratio
n=107 Participants
|
0.99 ratio
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Treated participants. Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.
Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48
LOCF Population (n=112; n=54)
|
-0.02 ratio
Standard Error 0.036
|
0.02 ratio
Standard Error 0.027
|
|
Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48
OCPopulation (n=105; n=51)
|
-0.01 ratio
Standard Error 0.038
|
0.02 ratio
Standard Error 0.029
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.
Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96
OC Population (n=94; n=45)
|
0.05 ratio
Standard Error 0.051
|
0.04 ratio
Standard Error 0.041
|
|
Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96
LOCF Population (n=112; n=54)
|
0.02 ratio
Standard Error 0.046
|
0.04 ratio
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: VAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint.
The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.)
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.
Week 48 VAT (n=98; n=53)
|
-0.4 Percent change
Interval -10.8 to 14.6
|
6.5 Percent change
Interval -13.8 to 25.7
|
|
Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.
Week 96 VAT (n=101; n=53)
|
2.1 Percent change
Interval -12.4 to 23.3
|
4.3 Percent change
Interval -11.7 to 26.5
|
|
Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.
Week 48 Trunk Fat (n=112; n=57)
|
-1.8 Percent change
Interval -10.0 to 9.2
|
2.6 Percent change
Interval -5.8 to 12.4
|
|
Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.
Week 96 Trunk Fat (n=112; n=57)
|
-3.6 Percent change
Interval -12.9 to 9.5
|
1.6 Percent change
Interval -6.7 to 14.3
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: SAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before analysis timepoint.
The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.)
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans
Week 48 Limb Fat (n=112; n=54)
|
-6.1 percent change
Interval -19.8 to 8.7
|
-0.8 percent change
Interval -11.3 to 12.2
|
|
Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans
Week 48 SAT (n=108; n=59)
|
-5.9 percent change
Interval -14.4 to 5.8
|
-2.2 percent change
Interval -11.6 to 8.7
|
|
Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans
Week 96 SAT (n=111; n=59)
|
-9.7 percent change
Interval -21.6 to 6.6
|
-3.5 percent change
Interval -15.7 to 8.7
|
|
Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans
Week 48 Limb Fat (n=112; 54)
|
-3.6 percent change
Interval -15.5 to 7.5
|
0.9 percent change
Interval -7.4 to 10.5
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: TAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint
The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other \[weight, etc\]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.)
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans
Week 48 TAT (n=108; n= 59)
|
-3.5 percent change
Interval -12.7 to 10.0
|
0.0 percent change
Interval -9.0 to 10.8
|
|
Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans
Week 96 TAT (n=111; n=59)
|
-5.0 percent change
Interval -16.0 to 10.4
|
-0.9 percent change
Interval -9.2 to 12.7
|
|
Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans
Week 48 Total Body Fat (n=105; n=51)
|
-3.7 percent change
Interval -10.9 to 5.1
|
1.9 percent change
Interval -5.4 to 11.5
|
|
Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans
Week 96 Total Body Fat (n=94; n=45)
|
-7.4 percent change
Interval -16.9 to 6.6
|
0.5 percent change
Interval -9.5 to 11.8
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Treated Subjects (LOCF). n=56 for LDL cholesterol in the PI/RTV arm at both timepoints
Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B
Outcome measures
| Measure |
PI/RTV Control Arm
n=57 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=122 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 48 - LDL Cholesterol
|
2.6 Percent change
|
-10.4 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 48 - Triglycerides
|
-11.7 Percent change
|
-23.8 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 96 - HDL Cholesterol
|
-4.6 Percent change
|
-6.8 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 96 - Non-HDL Cholesterol
|
1.2 Percent change
|
-14.0 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 48 - Total Cholesterol
|
-1.0 Percent change
|
-13.0 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 48 - HDL Cholesterol
|
-2.6 Percent change
|
-6.2 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 48 - Non-HDL Cholesterol
|
-0.6 Percent change
|
-14.8 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 48 - Apolipoprotein B
|
1.1 Percent change
|
-7.6 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 96 - Total Cholesterol
|
-0.1 Percent change
|
-12.5 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 96 - LDL Cholesterol
|
3.6 Percent change
|
-8.4 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 96 - Triglycerides
|
-12.2 Percent change
|
-25.0 Percent change
|
|
Mean Percent Changes From Baseline in Fasting Lipids
Week 96 - Apolipoprotein B
|
8.3 Percent change
|
-8.3 Percent change
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96
Week 48 (n=124; n=63)
|
-3.3 mg/dL
Standard Error 2.92
|
3.6 mg/dL
Standard Error 2.60
|
|
Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96
Week 96 (n=124; n=64)
|
3.0 mg/dL
Standard Error 2.88
|
1.2 mg/dL
Standard Error 2.82
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96
Baseline (n=124; n=62)
|
21.8 microunits per milliliter
Standard Error 3.36
|
14.1 microunits per milliliter
Standard Error 1.04
|
|
Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96
Week 48 (n=124; n=59)
|
-4.1 microunits per milliliter
Standard Error 3.79
|
1.3 microunits per milliliter
Standard Error 1.46
|
|
Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96
Week 96 (n=124; n=59)
|
0.3 microunits per milliliter
Standard Error 4.76
|
0.0 microunits per milliliter
Standard Error 1.20
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.
HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance.
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Week 48 (n=115; n=57)
|
-1.73 mg/dL x uU/mL
Standard Error 1.223
|
0.74 mg/dL x uU/mL
Standard Error 0.589
|
|
Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Baseline (n=115; n=59)
|
5.43 mg/dL x uU/mL
Standard Error 1.233
|
3.42 mg/dL x uU/mL
Standard Error 0.309
|
|
Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Week 96 (n=115; n=57)
|
1.00 mg/dL x uU/mL
Standard Error 1.648
|
0.28 mg/dL x uU/mL
Standard Error 0.500
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: LOCF; n=number of participants with baseline value and value at or before analysis timepoint
Outcome measures
| Measure |
PI/RTV Control Arm
n=68 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=130 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Changes From Baseline in Body Weight at Week 48 and Week 96
Week 48 (n=130; n=68)
|
-1 kg
Standard Error 0.4
|
1 kg
Standard Error 0.3
|
|
Mean Changes From Baseline in Body Weight at Week 48 and Week 96
Week 96 (n=130; n=68)
|
-1 kg
Standard Error 0.7
|
0 kg
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: LOCF; n=number of participants with baseline value and value at or before analysis timepoint
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96
Week 48 (n=123; n=66)
|
-1 cm
Standard Error 0.6
|
-1 cm
Standard Error 0.5
|
|
Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96
Week 96 (n=124; n=66)
|
-1 cm
Standard Error 0.8
|
-1 cm
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: LOCF; n=number of participants with baseline value and value at or before analysis timepoint
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96
Week 96 (n=130; n=67)
|
-0.5 kg/m2
Standard Error 0.25
|
0.2 kg/m2
Standard Error 0.13
|
|
Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96
Week 48 (n=130; n=67)
|
-0.2 kg/m2
Standard Error 0.13
|
0.3 kg/m2
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: LOCF; n=number of participants with baseline value and value at or before analysis timepoint
Mean changes from baseline in proportion of waist to hip measurements.
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96
Week 48 (n=123; n=65)
|
-0.01 ratio
Standard Error 0.007
|
-0.01 ratio
Standard Error 0.005
|
|
Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96
Week 96 (n=124; n=65)
|
-0.01 ratio
Standard Error 0.007
|
-0.01 ratio
Standard Error 0.006
|
SECONDARY outcome
Timeframe: Through Week 96 of study therapyPopulation: Treated participants
Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Death
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
SAE
|
7 Percentage of Participants
|
8 Percentage of Participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
AE Leading to Discontinuation
|
3 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
Any AEs (all grades) through Week 96
|
83 Percentage of Participants
|
90 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48, Week 96Population: All treated participants
Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests are graded using the modified World Health Organization (WHO) criteria. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling.
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 48 AST Grade 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 96 AST Grades 1-4
|
19 Percentage of Participants
|
24 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 48 TBILI Grades 3-4
|
0 Percentage of Participants
|
53 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 48 TBILI Grade 4
|
0 Percentage of Participants
|
13 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 96 TBILI Grades 1-4
|
21 Percentage of Participants
|
95 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 96 TBILI Grade 4
|
0 Percentage of Participants
|
17 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 48 ALT Grades 1-4
|
23 Percentage of Participants
|
34 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 48 ALT Grades 3-4
|
0 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 48 ALT Grade 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 96 ALT Grades 1-4
|
32 Percentage of Participants
|
37 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 96 ALT Grades 3-4
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 96 ALT Grade 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 48 AST Grade 1-4
|
15 Percentage of Participants
|
19 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 48 AST Grades 3-4
|
0 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 96 AST Grades 3-4
|
0 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 96 AST Grade 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 48 TBILI Grades 1-4
|
19 Percentage of Participants
|
94 Percentage of Participants
|
|
Percentage of Participants With Abnormal Liver Function Tests
Wk 96 TBILI Grades 3-4
|
0 Percentage of Participants
|
60 Percentage of Participants
|
SECONDARY outcome
Timeframe: Through Week 96Population: Treated subjects
Percentage of Participants with AEs leading to discontinuation of study therapy. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. All events listed in this table were SAEs, except for renal impairment and hypertriglycerideamia, which were an AEs (and did not meet the 5 percent threshold reported in Adverse Event module of this record).
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
Any adverse experience leading to discontinuation
|
3 Percent of Participants
|
5 Percent of Participants
|
|
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
Hyperbilirubinemia
|
0 Percent of Participants
|
2 Percent of Participants
|
|
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
Jaundice
|
0 Percent of Participants
|
1 Percent of Participants
|
|
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
Drug abuse
|
0 Percent of Participants
|
1 Percent of Participants
|
|
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
Renal impairment
|
0 Percent of Participants
|
1 Percent of Participants
|
|
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
Stevens-Johnson syndrome
|
0 Percent of Participants
|
1 Percent of Participants
|
|
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
Hypertriglyceridemia
|
1 Percent of Participants
|
0 Percent of Participants
|
|
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation
Squamous cell carcinoma
|
1 Percent of Participants
|
0 Percent of Participants
|
SECONDARY outcome
Timeframe: Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96Population: Treated subjects with HIV RNA \<400 c/mL at baseline.
Virologic rebound was measured from the first dose of study therapy to the first of the 2 consecutive measurements ≥400 c/mL. Time to virologic rebound was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative proportion of participants without virologic rebound up to the end of the respective interval.
Outcome measures
| Measure |
PI/RTV Control Arm
n=69 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=127 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
By Weeks 32-36
|
0.9841 Proportion of participants
|
0.9753 Proportion of participants
|
|
Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
By Weeks 44-48
|
0.9841 Proportion of participants
|
0.9669 Proportion of participants
|
|
Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
By Weeks 56-60
|
0.9841 Proportion of participants
|
0.9585 Proportion of participants
|
|
Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
By Weeks 68-72
|
0.9841 Proportion of participants
|
0.9585 Proportion of participants
|
|
Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
By Weeks 92-96
|
0.9309 Proportion of participants
|
0.9585 Proportion of participants
|
|
Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
By Weeks 8-12
|
1.000 Proportion of participants
|
0.9837 Proportion of participants
Interval 0.31 to 22.68
|
|
Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
By Weeks 20-24
|
1.000 Proportion of participants
|
0.9837 Proportion of participants
Interval 0.3 to 3.72
|
|
Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline
By Weeks 80-84
|
0.9674 Proportion of participants
|
0.9585 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48, Week 96Population: Observed Cases (OC)
Mean change from baseline in CD4 count among treated subjects
Outcome measures
| Measure |
PI/RTV Control Arm
n=68 Participants
Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
|
ATV/RTV Switch Arm
n=131 Participants
Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
|
|---|---|---|
|
Mean Change From Baseline in CD4 Count
Week 48 (n=114; n=56)
|
44 cells/mm3
Standard Error 19.4
|
14 cells/mm3
Standard Error 13.1
|
|
Mean Change From Baseline in CD4 Count
Week 96 (n=96; n=54)
|
82 cells/mm3
Standard Error 22.0
|
3 cells/mm3
Standard Error 16.9
|
Adverse Events
ATV/RTV Switch Arm
Serious events: 11 serious events
Other events: 94 other events
Deaths: 0 deaths
PI/RTV Control Arm
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATV/RTV Switch Arm
n=131 participants at risk
|
PI/RTV Control Arm
n=69 participants at risk
|
|---|---|---|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.76%
1/131
|
0.00%
0/69
|
|
Psychiatric disorders
DRUG ABUSE
|
0.76%
1/131
|
0.00%
0/69
|
|
Psychiatric disorders
DRUG DEPENDENCE
|
0.76%
1/131
|
0.00%
0/69
|
|
Hepatobiliary disorders
JAUNDICE
|
0.76%
1/131
|
0.00%
0/69
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
2.3%
3/131
|
0.00%
0/69
|
|
Nervous system disorders
PARALYSIS
|
0.76%
1/131
|
0.00%
0/69
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/131
|
1.4%
1/69
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.76%
1/131
|
0.00%
0/69
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/131
|
1.4%
1/69
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.76%
1/131
|
0.00%
0/69
|
|
Infections and infestations
PNEUMONIA
|
0.76%
1/131
|
0.00%
0/69
|
|
Infections and infestations
NEUROSYPHILIS
|
0.76%
1/131
|
0.00%
0/69
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/131
|
1.4%
1/69
|
|
Renal and urinary disorders
CALCULUS BLADDER
|
0.00%
0/131
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
STEVENS-JOHNSON SYNDROME
|
0.76%
1/131
|
0.00%
0/69
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.76%
1/131
|
0.00%
0/69
|
|
Injury, poisoning and procedural complications
JAW FRACTURE
|
0.00%
0/131
|
1.4%
1/69
|
|
Injury, poisoning and procedural complications
DRUG TOXICITY
|
0.76%
1/131
|
1.4%
1/69
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/131
|
1.4%
1/69
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.76%
1/131
|
0.00%
0/69
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.00%
0/131
|
1.4%
1/69
|
Other adverse events
| Measure |
ATV/RTV Switch Arm
n=131 participants at risk
|
PI/RTV Control Arm
n=69 participants at risk
|
|---|---|---|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
7.6%
10/131
|
2.9%
2/69
|
|
Hepatobiliary disorders
JAUNDICE
|
26.7%
35/131
|
0.00%
0/69
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
29.0%
38/131
|
1.4%
1/69
|
|
Nervous system disorders
HEADACHE
|
7.6%
10/131
|
4.3%
3/69
|
|
Gastrointestinal disorders
DIARRHOEA
|
7.6%
10/131
|
7.2%
5/69
|
|
Infections and infestations
INFLUENZA
|
7.6%
10/131
|
1.4%
1/69
|
|
Infections and infestations
SINUSITIS
|
3.8%
5/131
|
5.8%
4/69
|
|
Infections and infestations
BRONCHITIS
|
10.7%
14/131
|
5.8%
4/69
|
|
Infections and infestations
PHARYNGITIS
|
5.3%
7/131
|
0.00%
0/69
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.1%
8/131
|
2.9%
2/69
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.1%
4/131
|
7.2%
5/69
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
9.9%
13/131
|
18.8%
13/69
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.6%
6/131
|
8.7%
6/69
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.4%
11/131
|
5.8%
4/69
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER