Trial Outcomes & Findings for A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE) (NCT NCT01102972)
NCT ID: NCT01102972
Last Updated: 2013-11-19
Results Overview
The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit.
COMPLETED
PHASE4
297 participants
Week 24
2013-11-19
Participant Flow
Participants (PAR) were recruited from 44 centers in the United States, including Puerto Rico. ATV, atazanavir; RTV, ritonavir; TDF, tenofovir; FTC, emtricitrabine; QD, once daily; HIV-RNA, human immunodeficiency virus-ribonucleic acid; c, copies; ml, milliliters; ART, antiretroviral; mg, milligrams, ABC/3TC, abacavir sulfate/lamivudine.
HLA-B\*5701-negative PAR receiving an ATV/RTV + TDF/FTC regimen QD who are virologically suppressed (plasma HIV-1 RNA \<75 c/mL) and met all eligibility requirements were randomized 2:1 to receive an ART regimen of ATV 400 mg QD + ABC/3TC 600 mg/300 mg QD (simplification arm) or ATV/RTV 300 mg/100 mg QD + TDF/FTC 300 mg/200 mg QD (continuation arm).
Participant milestones
| Measure |
ABC/3TC + ATV
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
97
|
|
Overall Study
Completed Week 24
|
180
|
88
|
|
Overall Study
COMPLETED
|
170
|
83
|
|
Overall Study
NOT COMPLETED
|
29
|
14
|
Reasons for withdrawal
| Measure |
ABC/3TC + ATV
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
10
|
5
|
|
Overall Study
Investigator Discretion
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
Baseline Characteristics
A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)
Baseline characteristics by cohort
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
42.8 Years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 10.20 • n=7 Participants
|
42.6 Years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
65 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
120 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Number of participants with the indicated baseline HIV-RNA level
HIV-1 RNA <50
|
192 participants
n=5 Participants
|
93 participants
n=7 Participants
|
285 participants
n=5 Participants
|
|
Number of participants with the indicated baseline HIV-RNA level
HIV-1 RNA 50-<75
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Number of participants with the indicated baseline HIV-RNA level
HIV-1 RNA >=75
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Number of participants with the indicated Baseline CD4+ Cell Count
CD4+ cells <50
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Number of participants with the indicated Baseline CD4+ Cell Count
CD4+ cells 50-<200
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Number of participants with the indicated Baseline CD4+ Cell Count
CD4+ cells >=200
|
185 participants
n=5 Participants
|
91 participants
n=7 Participants
|
276 participants
n=5 Participants
|
|
Number of participants with the indicated Center for Disease Control (CDC) Classification
Class A: Asymptomatic/lymphadenopathy/acute HIV
|
136 participants
n=5 Participants
|
67 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Number of participants with the indicated Center for Disease Control (CDC) Classification
Class B: Symptomatic, not AIDS
|
26 participants
n=5 Participants
|
13 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Number of participants with the indicated Center for Disease Control (CDC) Classification
Class C: AIDS indicator conditions
|
37 participants
n=5 Participants
|
17 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Median Baseline CD4+ Cell Count
|
492.0 cells per cubic millimeter
n=5 Participants
|
480.0 cells per cubic millimeter
n=7 Participants
|
491.5 cells per cubic millimeter
n=5 Participants
|
|
Median Baseline HIV-1 RNA Level
|
1.591 log10 copies/mL
n=5 Participants
|
1.591 log10 copies/mL
n=7 Participants
|
1.591 log10 copies/mL
n=5 Participants
|
|
Number of participants with the indicated Baseline Hepatitis B (HB) Status
Reactive
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Number of participants with the indicated Baseline Hepatitis B (HB) Status
Non-reactive
|
199 participants
n=5 Participants
|
97 participants
n=7 Participants
|
296 participants
n=5 Participants
|
|
Number of participants with the indicated Baseline Hepatitis C (HC) Status
Reactive
|
18 participants
n=5 Participants
|
8 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Number of participants with the indicated Baseline Hepatitis C (HC) Status
Non-reactive
|
181 participants
n=5 Participants
|
89 participants
n=7 Participants
|
270 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intent-to-Treat (ITT)-Exposed Population: all participants exposed to at least one dose of study medication. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA \<50 copies/mL at Week 24.
The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis
|
86.9 percentage of participants
|
86.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load \>=50 c/mL were failures.
The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses
Observed, n=181, 89
|
94.5 percentage of participants
|
97.7 percentage of participants
|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses
M/D=F, n=199, 97
|
84.9 percentage of participants
|
87.6 percentage of participants
|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses
SNAPSHOT, n=199, 97
|
84.9 percentage of participants
|
88.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load \>=50 c/mL were failures.
The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses
TLOVR, n=199, 97
|
76.4 Percentage of participants
|
79.4 Percentage of participants
|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses
Observed, n=169, 82
|
91.1 Percentage of participants
|
96.3 Percentage of participants
|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses
M/D=F, n=199, 97
|
76.9 Percentage of participants
|
79.4 Percentage of participants
|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses
SNAPSHOT, n=199, 97
|
77.4 Percentage of participants
|
81.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT-E Population. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA \<400 copies/mL at Week 24.
The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis
|
88.4 percentage of participants
|
86.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population
The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis
|
81 Percentage of participants
|
84 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load \>=400 c/mL were failures.
The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses
Observed, n=181, 89
|
98.9 percentage of participants
|
98.9 percentage of participants
|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses
M/D=F, n=199, 97
|
88.9 percentage of participants
|
88.7 percentage of participants
|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses
SNAPSHOT, n=199, 97
|
89.4 percentage of participants
|
89.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load \>=400 c/mL were failures.
The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses
Observed, n=169, 82
|
96 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses
M/D=F, n=199, 97
|
81 Percentage of participants
|
82 Percentage of participants
|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses
SNAPSHOT, n=199, 97
|
82 Percentage of participants
|
85 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a viral load result obtained during that visit period.
Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.
Outcome measures
| Measure |
ABC/3TC + ATV
n=181 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=89 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Change From Baseline in HIV-1 RNA at Week 24
|
0.014 log10 copies/mL
Standard Deviation 0.271
|
0.008 log10 copies/mL
Standard Deviation 0.352
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a viral load result obtained during that visit period.
Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.
Outcome measures
| Measure |
ABC/3TC + ATV
n=169 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=82 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Change From Baseline in HIV-1 RNA at Week 48
|
0.071 log10 copies/mL
Standard Deviation 0.448
|
-0.018 log10 copies/mL
Standard Deviation 0.198
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a CD4+ cell count obtained during that visit period.
Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
ABC/3TC + ATV
n=181 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=89 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 24
|
47.7 cells per cubic millimeter (mm^3)
Standard Deviation 134.02
|
8.3 cells per cubic millimeter (mm^3)
Standard Deviation 122.40
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a CD4+ cell count obtained during that visit period.
Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 48 value minus the Baseline value.
Outcome measures
| Measure |
ABC/3TC + ATV
n=169 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=83 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48
|
95.8 cells per cubic millimeter (mm^3)
Standard Deviation 158.93
|
57.2 cells per cubic millimeter (mm^3)
Standard Deviation 139.84
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.
Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter.
Outcome measures
| Measure |
ABC/3TC + ATV
n=170 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=81 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24
Triglycerides, n=170, 81
|
-17.23 milligrams per deciliter (mg/dL)
Standard Deviation 62.29
|
-4.35 milligrams per deciliter (mg/dL)
Standard Deviation 63.00
|
|
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24
Total cholesterol, n=170, 81
|
4.49 milligrams per deciliter (mg/dL)
Standard Deviation 26.37
|
0.14 milligrams per deciliter (mg/dL)
Standard Deviation 26.24
|
|
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24
HDL cholesterol, n=170, 81
|
4.50 milligrams per deciliter (mg/dL)
Standard Deviation 8.78
|
-0.20 milligrams per deciliter (mg/dL)
Standard Deviation 8.73
|
|
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24
LDL cholesterol (Calculation), n=166, 80
|
3.34 milligrams per deciliter (mg/dL)
Standard Deviation 22.48
|
0.94 milligrams per deciliter (mg/dL)
Standard Deviation 25.72
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.
A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
ABC/3TC + ATV
n=170 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=81 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Change From Baseline in Cholesterol/HDL Ratio at Week 24
|
-0.20 ratio
Standard Deviation 0.57
|
-0.01 ratio
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.
Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.
Outcome measures
| Measure |
ABC/3TC + ATV
n=152 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=76 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48
Triglycerides, n=152, 76
|
-9.28 milligrams per deciliter (mg/dL)
Standard Deviation 65.39
|
7.71 milligrams per deciliter (mg/dL)
Standard Deviation 91.00
|
|
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48
Total cholesterol, n=152, 76
|
7.62 milligrams per deciliter (mg/dL)
Standard Deviation 31.04
|
0.62 milligrams per deciliter (mg/dL)
Standard Deviation 29.90
|
|
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48
HDL cholesterol, n=152, 76
|
3.11 milligrams per deciliter (mg/dL)
Standard Deviation 9.33
|
0.53 milligrams per deciliter (mg/dL)
Standard Deviation 9.58
|
|
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48
LDL cholesterol (Calculation), n=148, 71
|
5.28 milligrams per deciliter (mg/dL)
Standard Deviation 26.35
|
-0.62 milligrams per deciliter (mg/dL)
Standard Deviation 28.21
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.
A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.
Outcome measures
| Measure |
ABC/3TC + ATV
n=152 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=76 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Change From Baseline in Cholesterol/HDL Ratio at Week 48
|
0.00 ratio
Standard Deviation 0.97
|
0.00 ratio
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT-E Population
The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA \>=400 c/mL.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: ITT-E Population
The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA \>=400 c/mL.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: ITT-E Population
Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, \>=500 cells per microliter \[µl\]; Class B, 200-499 cells/µl; Class C, \<200 cells/µl) and on previously diagnosed HIV-related conditions.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Number of Participants Who Experienced Death and/or Disease Progression
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.
A blood sample was drawn for particiapants with confirmed VF \>=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Outcome measures
| Measure |
ABC/3TC + ATV
n=2 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=1 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24
PAR with treatment-emergent mutations
|
2 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24
PAR with NRTI mutations
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24
PAR with NNRTI mutations
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24
PAR with major PI mutations
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24
PAR with minor PI mutations
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.
A blood sample was drawn for particiapants with confirmed VF \>=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Outcome measures
| Measure |
ABC/3TC + ATV
n=4 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=1 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48
PAR with NRTI mutations
|
2 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48
PAR with major NNRTI mutations
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48
PAR with major PI mutations
|
2 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48
PAR with minor PI mutations
|
4 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48
PAR with treatment-emergent mutations
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.
Outcome measures
| Measure |
ABC/3TC + ATV
n=2 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=1 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced abacavir susceptibility
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced lamivudine susceptibility
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced tenofovir susceptibility
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced emtricitabine susceptibility
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced atazanavir susceptibility
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced ritonavir susceptibility
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.
Outcome measures
| Measure |
ABC/3TC + ATV
n=4 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=1 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced tenofovir susceptibility
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced atazanavir susceptibility
|
2 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced ritonavir susceptibility
|
2 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced abacavir susceptibility
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced lamivudine susceptibility
|
2 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
HIV PAR with reduced emtricitabine susceptibility
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Safety Population
The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Diarrhoea
|
5 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Bronchitis
|
4 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Rash
|
6 participants
|
0 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Muscle strain
|
2 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Muscle spasms
|
1 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Sinusitis
|
1 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Upper respiratory tract infection
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 48Population: Safety Population
The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.
Outcome measures
| Measure |
ABC/3TC + ATV
n=199 Participants
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 Participants
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Any Event
|
90 participants
|
44 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Upper respiratory tract infection
|
11 participants
|
7 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Diarrhoea
|
7 participants
|
4 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Depression
|
6 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Back pain
|
4 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Bronchitis
|
4 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Insomnia
|
6 participants
|
0 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Muscle strain
|
3 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Rash
|
6 participants
|
0 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Muscle spasms
|
2 participants
|
3 participants
|
|
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Sinusitis
|
2 participants
|
4 participants
|
Adverse Events
ABC/3TC + ATV
TDF/FTC + ATV/RTV
Serious adverse events
| Measure |
ABC/3TC + ATV
n=199 participants at risk
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 participants at risk
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
1.5%
3/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Pneumonia
|
1.0%
2/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Staphyloccal abscess
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Bronchopneumonia
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Gastroenteritis shigella
|
0.00%
0/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
1.0%
1/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
1.0%
1/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Sepsis
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Subcutaneous abscess
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
1.0%
1/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Gastrointestinal disorders
Colitis
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
1.0%
1/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Cardiac disorders
Cardiomyopathy
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
General disorders
Chest pain
|
1.0%
2/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
1.0%
1/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Immune system disorders
Drug hypersensitivity
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
1.0%
1/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Psychiatric disorders
Depression
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Psychiatric disorders
Suicide attempt
|
1.0%
2/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.50%
1/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
Other adverse events
| Measure |
ABC/3TC + ATV
n=199 participants at risk
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
|
TDF/FTC + ATV/RTV
n=97 participants at risk
Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.1%
28/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
4.1%
4/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
22/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
12.4%
12/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Nervous system disorders
Headache
|
9.5%
19/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
5.2%
5/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
15/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
4.1%
4/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
15/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
1.0%
1/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Bronchitis
|
5.5%
11/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
7.2%
7/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Psychiatric disorders
Insomnia
|
6.0%
12/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
3.1%
3/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Infections and infestations
Sinusitis
|
4.5%
9/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
7.2%
7/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
General disorders
Fatigue
|
7.0%
14/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
1.0%
1/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
11/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
3.1%
3/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
9/199 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
5.2%
5/97 • Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 48 are presented in this summary.
|
Additional Information
GSK Response Center
ViiV Healthcare
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER