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Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection

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ClinicalTrials.gov Identifier: NCT00440947
Recruitment Status : Completed
First Posted : February 27, 2007
Results First Posted : August 17, 2011
Last Update Posted : March 22, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Infection, Human Immunodeficiency Virus I
HIV Infection
Interventions Drug: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)
Drug: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)
Enrollment 515
Recruitment Details Participants (PAR) were recruited at 66 centers in the United States of America and Canada. HIV-RNA, human immunodeficiency virus-ribonucleic acid; ml, milliliters.
Pre-assignment Details The study had a 36-week Non-randomized Induction Phase, followed by an 84-week Randomized Phase. All PAR completing 84 weeks were eligible to enter an optional 60-week extension phase (EP); some PAR chose not to continue in the EP. PAR whose HIV-RNA wasn't <50 copies/ml before Week 36 weren't allowed to randomize at Week 36 and were withdrawn.
Arm/Group Title ABC/3TC + ATV/r: Induction Phase ABC/3TC + ATV: Randomization Phase ABC/3TC + ATV/r: Randomization Phase ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis) Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
Period Title: 36-Week Induction Phase
Started 515 0 0 0 0
Completed 442 [1] 0 0 0 0
Not Completed 73 0 0 0 0
Reason Not Completed
Adverse Event             16             0             0             0             0
Insufficient Viral Load Response             11             0             0             0             0
Protocol-defined Virologic Failure             5             0             0             0             0
Non-compliance             10             0             0             0             0
Lost to Follow-up             16             0             0             0             0
Withdrawal by Subject             7             0             0             0             0
Kaposi Lesions Requiring Chemotherapy             1             0             0             0             0
Took Exclusionary Medications             1             0             0             0             0
Genotype Had Exclusionary Mutations             1             0             0             0             0
Fleeing Police; Outstanding Warrants             1             0             0             0             0
Incarceration             3             0             0             0             0
Pregnancy             1             0             0             0             0
[1]
23 PAR without confirmed HIV-RNA<50c/mL prior to Wk 36 couldn’t be randomized but weren’t withdrawn.
Period Title: 48-Week Randomization Phase
Started 0 210 209 0 0
Completed 0 194 185 0 0
Not Completed 0 16 24 0 0
Reason Not Completed
Adverse Event             0             2             5             0             0
Protocol-defined Virologic Failure             0             1             1             0             0
Non-compliance             0             3             4             0             0
Lost to Follow-up             0             2             8             0             0
Protocol Violation             0             0             1             0             0
Withdrawal by Subject             0             2             4             0             0
Pregnancy             0             0             1             0             0
Incarceration             0             3             0             0             0
Trying to Get Pregnant             0             1             0             0             0
Physician Decision             0             2             0             0             0
Period Title: Optional 60-Week Extension Phase
Started 0 0 0 189 180
Completed 0 0 0 160 154
Not Completed 0 0 0 29 26
Reason Not Completed
Adverse Event             0             0             0             1             3
Insufficient Viral Load Response             0             0             0             1             1
Protocol-defined Virologic Failure             0             0             0             3             2
Non-compliance             0             0             0             1             1
Lost to Follow-up             0             0             0             9             9
Protocol Violation             0             0             0             1             0
Withdrawal by Subject             0             0             0             4             3
Pregnancy             0             0             0             3             0
Participant Moved             0             0             0             1             1
Sponsor Request             0             0             0             1             1
Sponsor Terminated Site             0             0             0             3             3
Other             0             0             0             1             0
Physician Decision             0             0             0             0             1
Participant Remained in Cuba             0             0             0             0             1
Arm/Group Title ABC/3TC + ATV/r
Hide Arm/Group Description All participants starting the Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
Overall Number of Baseline Participants 515
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 515 participants
38.3  (10.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 515 participants
Female
86
  16.7%
Male
429
  83.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 515 participants
African American/African Heritage 167
American Indian or Alaskan Native 9
Asian - Central/South Asian Heritage 4
Asian - East Asian Heritage 3
Asian - Japanese Heritage 1
Asian - South East Asian Heritage 3
Native Hawaiian or Other Pacific Islander 1
White - Arabic/North African Heritage 5
White - White/Caucasian/European Heritage 316
Mixed Race 6
Number of participants with the indicated baseline HIV-RNA level   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 515 participants
HIV-1 RNA <100,000 227
HIV-1 RNA 100,000-<250,000 143
HIV-1 RNA 250,000-<500,000 73
HIV-1 RNA >=500,000 72
[1]
Measure Description: HIV-1 RNA, Human Immunodeficiency Virus type 1 Ribonucleic acid. HIV-1 viral load was measured as virus copies per milliliter (ml) at baseline.
Number of participants with the indicated Baseline CD4+ Cell Count   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 515 participants
CD4+ cells <50 69
CD4+ cells 50-<200 190
CD4+ cells >=200 256
[1]
Measure Description: A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts.
Number of participants with the indicated Center for Disease Control (CDC) Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 515 participants
Asymptomatic HIV Infection 353
Symptomatic (non-AIDS) condition 97
AIDS 65
[1]
Measure Description: AIDS, Acquired Immunodeficiency Syndrome CDC classifications are Asymptomatic, Symptomatic, or AIDs.
Median Baseline CD4+ Cell Count  
Median (Full Range)
Unit of measure:  Cells per cubic millimeter
Number Analyzed 515 participants
199
(19 to 754)
Median Baseline HIV-1 RNA Level  
Median (Full Range)
Unit of measure:  Log10 copies/ml
Number Analyzed 515 participants
5.076
(2.989 to 6.620)
1.Primary Outcome
Title Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
Hide Description The percentage of PAR with HIV-1 RNA virus <50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 c/ml and >=100,000 c/ml). 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 last visit.
Time Frame Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT)-Exposed Population, Randomized Phase: all PAR exposed to at least one dose of study medication during the Randomized Phase of the study. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of PAR with HIV-1 RNA <50 c/ml at Week 84 in the Simplification arm and Continuation arms
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 210 209
Measure Type: Number
Unit of Measure: percentage of participants
86 81
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC + ATV: Randomized Phase, ABC/3TC + ATV/r: Randomized Phase
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) on the difference in the percentage of participants with HIV-1 RNA <50 c/mL at Week 84 was -12% or greater.
Statistical Test of Hypothesis P-Value 0.140
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments p-value was obtained from Cochran-Mantel-Haenszel stratified by baseline HIV-1 RNA (<100000/>=100000)
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-1.8 to 12.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase
Hide Description The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline.
Time Frame Baseline of Randomized Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population: all participants exposed to at least one dose of study medication during the Randomized Simplification Phase
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 210 209
Mean (Standard Deviation)
Unit of Measure: years
37.5  (10.23) 39.7  (9.71)
3.Secondary Outcome
Title Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit
Hide Description The percentage of PAR with HIV-1 RNA virus <50 c/ml from a Week 36 blood sample was tabulated. 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 (DC) study or study medication (any reason), had confirmed rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures.
Time Frame Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Induction Phase: all participants exposed to at least one dose of study medication during the Induction Phase of the study
Arm/Group Title ABC/3TC + ATV/r: Induction Phase
Hide Arm/Group Description:
Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
Overall Number of Participants Analyzed 515
Measure Type: Number
Unit of Measure: percentage of participants
TLOVR 80
Obs 88
M/D=F 77
4.Secondary Outcome
Title Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA <50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures.
Time Frame Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Randomized Phase. The secondary analysis methods were Observed (Obs) and missing/discontinuation=failure (M/D=F) analyses.
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 210 209
Measure Type: Number
Unit of Measure: percentage of participants
Obs 92 92
M/D=F 85 82
5.Secondary Outcome
Title Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit
Hide Description Percentage of PAR with HIV-1 RNA <50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Time Frame Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-Extension Population, Extension Phase: all participants exposed to at least one dose of study medication during the Extension Phase of the study
Arm/Group Title ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description:
Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 189 180
Measure Type: Number
Unit of Measure: percentage of participants
TLOVR 77 73
Obs 95 92
M/D=F 80 78
6.Secondary Outcome
Title Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit
Hide Description The percentage of PAR with HIV-1 RNA virus <400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Time Frame Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Induction Phase
Arm/Group Title ABC/3TC + ATV/r: Induction Phase
Hide Arm/Group Description:
Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
Overall Number of Participants Analyzed 515
Measure Type: Number
Unit of Measure: percentage of participants
TLOVR 82
Obs 98
M/D=F 84
7.Secondary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit
Hide Description Percentage of PAR with HIV-1 RNA <400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Time Frame Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Randomized Phase
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 210 209
Measure Type: Number
Unit of Measure: percentage of participants
TLOVR 92 86
Obs 99 98
M/D=F 92 87
8.Secondary Outcome
Title Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit
Hide Description Percentage of PAR with HIV-1 RNA <400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Time Frame Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-Extension Population, Extension Phase
Arm/Group Title ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description:
Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 189 180
Measure Type: Number
Unit of Measure: percentage of participants
TLOVR 84 80
Obs 99 97
M/D=F 84 82
9.Secondary Outcome
Title Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36
Hide Description The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.
Time Frame Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Induction Phase
Arm/Group Title ABC/3TC + ATV/r: Induction Phase
Hide Arm/Group Description:
Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
Overall Number of Participants Analyzed 515
Measure Type: Number
Unit of Measure: participants
Protocol-defined virologic failure 15
Failure to achieve <400 c/ml by Week 30 5
Confirmed rebound after achieving <400 c/ml 10
10.Secondary Outcome
Title Number of Participants Who Met the PDVF Criteria at Week 84
Hide Description The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.
Time Frame Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-Exposed Population, Randomized Phase. TLOVR. One participant met PDVF criteria at Week 36 and was included in the Week 36 PDVF but had been randomized; this participant is therefore also included in this PDVF tabulation.
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 210 209
Measure Type: Number
Unit of Measure: participants
Protocol-defined virologic failure 1 7
Confirmed rebound after achieving <400 c/ml 1 7
11.Secondary Outcome
Title Number of Participants Who Met the PDVF Criteria at Week 144
Hide Description The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.
Time Frame Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-Extension Population, Extension Phase. TLOVR.
Arm/Group Title ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description:
Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 210 209
Measure Type: Number
Unit of Measure: participants
Protocol-defined virologic failure 5 6
Confirmed rebound after achieving <400 c/ml 5 6
12.Secondary Outcome
Title Change From Baseline in HIV-1 RNA at Week 36
Hide Description Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time Frame Baseline and Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Induction Phase. Observed Population. Participants could only be included in the analysis if they had completed a Week 36 visit and had a viral load result obtained during that visit period.
Arm/Group Title ABC/3TC + ATV/r: Induction Phase
Hide Arm/Group Description:
Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
Overall Number of Participants Analyzed 447
Mean (Standard Deviation)
Unit of Measure: log10 c/ml
-3.241  (0.775)
13.Secondary Outcome
Title Change From Baseline in HIV-1 RNA at Week 84
Hide Description Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time Frame Baseline and Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a viral load result obtained during that visit period.
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 194 187
Mean (Standard Deviation)
Unit of Measure: log10 c/ml
-3.261  (0.681) -3.270  (0.698)
14.Secondary Outcome
Title Change From Baseline in HIV-1 RNA at Week 144
Hide Description Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time Frame Baseline and Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a viral load result obtained during that visit period.
Arm/Group Title ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description:
Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 163 154
Mean (Standard Deviation)
Unit of Measure: log10 c/ml
-3.291  (0.675) -3.239  (0.835)
15.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 36
Hide Description 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 36 value minus the baseline value.
Time Frame Baseline and Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Induction Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 36 visit and had a cell count obtained during that visit period.
Arm/Group Title ABC/3TC + ATV/r: Induction Phase
Hide Arm/Group Description:
Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
Overall Number of Participants Analyzed 438
Mean (Standard Deviation)
Unit of Measure: cells/millimeters cubed (mm^3)
185.4  (121.84)
16.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 84
Hide Description 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 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.
Time Frame Baseline and Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a cell count obtained during that visit period.
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 193 187
Mean (Standard Deviation)
Unit of Measure: cells/millimeters cubed (mm^3)
265.7  (157.65) 282.9  (150.49)
17.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 144
Hide Description 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 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.
Time Frame Baseline and Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a cell count obtained during that visit period.
Arm/Group Title ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description:
Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 163 156
Mean (Standard Deviation)
Unit of Measure: cells/millimeters cubed (mm^3)
317.7  (161.98) 325.1  (178.29)
18.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
Hide Description A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. 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 mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time Frame Baseline through Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
Arm/Group Title ABC/3TC + ATV/r: Induction Phase
Hide Arm/Group Description:
Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
PAR with paired genotypes at baseline and VF 15
PAR with treatment-emergent mutations 6
PAR with NRTI mutations 4
PAR with NNRTI mutations 1
PAR with major PI mutations 0
PAR with minor PI mutations 2
19.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
Hide Description A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time Frame Randomization at Week 36 through Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT-E Population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 1 7
Measure Type: Number
Unit of Measure: participants
PAR with paired genotypes at baseline and VF 1 7
PAR with treatment-emergent mutations 1 2
PAR with NRTI mutations 1 0
PAR with NNRTI mutations 0 0
PAR with major PI mutations 0 0
PAR with minor PI mutations 0 2
20.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
Hide Description A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time Frame Week 84 through Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations.
Arm/Group Title ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description:
Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: participants
PAR with paired genotypes at baseline and VF 5 5
PAR with treatment-emergent mutations 2 1
PAR with NRTI mutations 0 1
PAR with NNRTI mutations 0 0
PAR with major PI mutations 0 1
PAR with minor PI mutations 2 1
21.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
Hide Description 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. PAR, participant.
Time Frame Baseline through Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
Arm/Group Title ABC/3TC + ATV/r: Induction Phase
Hide Arm/Group Description:
Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
PAR with reduced abacavir susceptibility 0
PAR with reduced lamivudine susceptibility 1
PAR with reduced atazanavir susceptibility 0
PAR with reduced ritonavir susceptibility 0
22.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
Hide Description 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. PAR, participant.
Time Frame Randomization at Week 36 through Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT-E population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 1 7
Measure Type: Number
Unit of Measure: participants
PAR with reduced abacavir susceptibility 0 0
PAR with reduced lamivudine susceptibility 1 0
PAR with reduced atazanavir susceptibility 0 0
PAR with reduced ritonavir susceptibility 0 0
23.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
Hide Description 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. PAR, participant.
Time Frame Week 84 through Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure phenotypic evaluations
Arm/Group Title ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description:
Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: participants
PAR with reduced abacavir susceptibility 0 1
PAR with reduced lamivudine susceptibility 1 1
PAR with reduced atazanavir susceptibility 0 1
PAR with reduced ritonavir susceptibility 0 1
24.Secondary Outcome
Title Mean Percent Compliance at Week 36
Hide Description Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.
Time Frame Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Induction Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.
Arm/Group Title ABC/3TC + ATV/r: Induction Phase
Hide Arm/Group Description:
Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
Overall Number of Participants Analyzed 503
Mean (Standard Deviation)
Unit of Measure: percent compliance
Abacavir/Lamivudine 92.2  (13.05)
Ritonavir 92.3  (12.15)
Atazanavir 92.7  (12.50)
25.Secondary Outcome
Title Mean Percent Compliance at Week 84
Hide Description Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.
Time Frame Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population, Randomized Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.
Arm/Group Title ABC/3TC + ATV: Randomized Phase ABC/3TC + ATV/r: Randomized Phase
Hide Arm/Group Description:
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 210 209
Mean (Standard Deviation)
Unit of Measure: percent compliance
Abacavir/Lamivudine 92.0  (11.62) 91.2  (13.49)
Ritonavir 92.9  (11.64) 91.5  (12.23)
Atazanavir 98.9  (5.32) 92.4  (11.89)
26.Secondary Outcome
Title Mean Percent Compliance at Week 144
Hide Description Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.
Time Frame Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-Extension Population, Extension Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.
Arm/Group Title ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description:
Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
Overall Number of Participants Analyzed 189 180
Mean (Standard Deviation)
Unit of Measure: percent compliance
Abacavir/Lamivudine 92.0  (12.65) 90.1  (15.35)
Ritonavir 93.3  (11.07) 90.1  (14.58)
Atazanavir 99.1  (4.54) 91.4  (13.99)
Time Frame [Not Specified]
Adverse Event Reporting Description Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at >=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is >=3% for at least one arm.
 
Arm/Group Title ABC/3TC + ATV/r: Induction Phase ABC/3TC + ATV: Randomization Phase ABC/3TC + ATV/r: Randomization Phase ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Hide Arm/Group Description Induction Phase: participants in the Safety Population (participants exposed to at least one dose of investigational product) receiving abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis) Randomization Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD; includes serious adverse events (SAEs) that occurred during induction phase Randomization Phase: participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD; includes SAEs that occurred during induction phase Extension Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
All-Cause Mortality
ABC/3TC + ATV/r: Induction Phase ABC/3TC + ATV: Randomization Phase ABC/3TC + ATV/r: Randomization Phase ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ABC/3TC + ATV/r: Induction Phase ABC/3TC + ATV: Randomization Phase ABC/3TC + ATV/r: Randomization Phase ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/515 (7.57%)   22/210 (10.48%)   22/209 (10.53%)   24/189 (12.70%)   24/180 (13.33%) 
Cardiac disorders           
Angina unstable  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Ear and labyrinth disorders           
Vertigo  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Endocrine disorders           
Hyperparathyroidism  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  0/180 (0.00%) 
Eye disorders           
Vision blurred  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Colitis  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Diarrhoea  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Gastritis  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Nausea  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  2/189 (1.06%)  0/180 (0.00%) 
Pancreatitis  1  1/515 (0.19%)  0/210 (0.00%)  1/209 (0.48%)  1/189 (0.53%)  1/180 (0.56%) 
Vomiting  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  2/189 (1.06%)  0/180 (0.00%) 
Rectal haemorrhage  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Small intestinal obstruction  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
General disorders           
Chest pain  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Non-cardiac chest pain  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  2/189 (1.06%)  0/180 (0.00%) 
Pyrexia  1  1/515 (0.19%)  1/210 (0.48%)  1/209 (0.48%)  1/189 (0.53%)  0/180 (0.00%) 
Hepatobiliary disorders           
Cholecystitis  1  0/515 (0.00%)  0/210 (0.00%)  1/209 (0.48%)  0/189 (0.00%)  1/180 (0.56%) 
Hepatic failure  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  0/180 (0.00%) 
Hepatotoxicity  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  1/180 (0.56%) 
Hyperbilirubinaemia  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Immune system disorders           
Drug hypersensitivity  1  5/515 (0.97%)  2/210 (0.95%)  3/209 (1.44%)  1/189 (0.53%)  4/180 (2.22%) 
Hypersensitivity  1  1/515 (0.19%)  0/210 (0.00%)  1/209 (0.48%)  0/189 (0.00%)  1/180 (0.56%) 
Infections and infestations           
Appendicitis  1  3/515 (0.58%)  2/210 (0.95%)  1/209 (0.48%)  1/189 (0.53%)  2/180 (1.11%) 
Appendicitis, perforated  1  0/515 (0.00%)  1/210 (0.48%)  1/209 (0.48%)  1/189 (0.53%)  1/180 (0.56%) 
Pneumocystis jiroveci pneumonia  1  2/515 (0.39%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  0/180 (0.00%) 
Pneumonia  1  2/515 (0.39%)  0/210 (0.00%)  1/209 (0.48%)  1/189 (0.53%)  1/180 (0.56%) 
Bronchitis  1  1/515 (0.19%)  0/210 (0.00%)  1/209 (0.48%)  2/189 (1.06%)  0/180 (0.00%) 
Cellulitis  1  1/515 (0.19%)  2/210 (0.95%)  0/209 (0.00%)  4/189 (2.12%)  0/180 (0.00%) 
Peritoneal infection  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Genital herpes  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Shigella infection  1  0/515 (0.00%)  0/210 (0.00%)  1/209 (0.48%)  0/189 (0.00%)  1/180 (0.56%) 
Clostridium difficile colitis  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  0/189 (0.00%)  0/180 (0.00%) 
Gastroenteritis viral  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Lobar pneumonia  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  0/180 (0.00%) 
Meningitis aseptic  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Proctitis gonococcal  1  1/515 (0.19%)  0/210 (0.00%)  1/209 (0.48%)  0/189 (0.00%)  0/180 (0.00%) 
Sinusitis  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Staphylococcal infection  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Viral upper respiratory tract infection  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Injury, poisoning and procedural complications           
Alcohol poisoning  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  1/180 (0.56%) 
Ankle fracture  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Contusion  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Fall  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Foot fracture  1  1/515 (0.19%)  0/210 (0.00%)  1/209 (0.48%)  0/189 (0.00%)  1/180 (0.56%) 
Post lumbar puncture syndrome  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Therapeutic agent toxicity  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  1/180 (0.56%) 
Investigations           
Hepatic enzyme increased  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  1/180 (0.56%) 
Metabolism and nutrition disorders           
Hyperglycaemia  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Metabolic acidosis  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Musculoskeletal and connective tissue disorders           
Rhabdomyolysis  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Syncope  1  2/515 (0.39%)  1/210 (0.48%)  1/209 (0.48%)  1/189 (0.53%)  1/180 (0.56%) 
Burkitt’s lymphoma  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  0/180 (0.00%) 
Diffuse large B-cell lymphoma  1  0/515 (0.00%)  0/210 (0.00%)  1/209 (0.48%)  0/189 (0.00%)  0/180 (0.00%) 
Castleman’s disease  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  0/180 (0.00%) 
Pharyngeal neoplasm  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  0/180 (0.00%) 
Squamous cell carcinoma  1  0/515 (0.00%)  0/210 (0.00%)  1/209 (0.48%)  0/189 (0.00%)  0/180 (0.00%) 
Uterine leiomyoma  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Cervix carcinoma stage II  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  1/180 (0.56%) 
Lung adenocarcinoma  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  1/180 (0.56%) 
Nervous system disorders           
Convulsion  1  2/515 (0.39%)  1/210 (0.48%)  1/209 (0.48%)  1/189 (0.53%)  0/180 (0.00%) 
Cerebrovascular accident  1  1/515 (0.19%)  0/210 (0.00%)  2/209 (0.96%)  0/189 (0.00%)  2/180 (1.11%) 
Cerebral infarction  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  1/180 (0.56%) 
Headache  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Transient ischaemic attack  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  0/180 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Psychiatric disorders           
Depression  1  1/515 (0.19%)  1/210 (0.48%)  1/209 (0.48%)  0/189 (0.00%)  1/180 (0.56%) 
Mental disorder  1  1/515 (0.19%)  0/210 (0.00%)  1/209 (0.48%)  0/189 (0.00%)  1/180 (0.56%) 
Suicidal ideation  1  0/515 (0.00%)  1/210 (0.48%)  1/209 (0.48%)  1/189 (0.53%)  1/180 (0.56%) 
Suicide attempt  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Renal and urinary disorders           
Nephrolithiasis  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Renal failure  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Chronic obstructive pulmonary disease  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Dyspnoea  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Pneumonia aspiration  1  0/515 (0.00%)  0/210 (0.00%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Pulmonary embolism  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Skin and subcutaneous tissue disorders           
Hypoaesthesia facial  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Angioedema  1  0/515 (0.00%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Vascular disorders           
Peripheral vascular disorder  1  0/515 (0.00%)  0/210 (0.00%)  1/209 (0.48%)  0/189 (0.00%)  1/180 (0.56%) 
Deep vein thrombosis  1  1/515 (0.19%)  0/210 (0.00%)  0/209 (0.00%)  0/189 (0.00%)  1/180 (0.56%) 
Hypertensive crisis  1  1/515 (0.19%)  1/210 (0.48%)  0/209 (0.00%)  1/189 (0.53%)  0/180 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
ABC/3TC + ATV/r: Induction Phase ABC/3TC + ATV: Randomization Phase ABC/3TC + ATV/r: Randomization Phase ABC/3TC + ATV: Extension Phase ABC/3TC + ATV/r: Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   237/515 (46.02%)   116/210 (55.24%)   123/209 (58.85%)   123/189 (65.08%)   130/180 (72.22%) 
Eye disorders           
Conjunctivitis  1  7/515 (1.36%)  3/210 (1.43%)  4/209 (1.91%)  3/189 (1.59%)  6/180 (3.33%) 
Gastrointestinal disorders           
Diarrhoea  1  42/515 (8.16%)  24/210 (11.43%)  23/209 (11.00%)  25/189 (13.23%)  21/180 (11.67%) 
Nausea  1  24/515 (4.66%)  12/210 (5.71%)  10/209 (4.78%)  9/189 (4.76%)  12/180 (6.67%) 
Abdominal pain  1  4/515 (0.78%)  6/210 (2.86%)  3/209 (1.44%)  6/189 (3.17%)  4/180 (2.22%) 
Vomiting  1  9/515 (1.75%)  6/210 (2.86%)  4/209 (1.91%)  6/189 (3.17%)  3/180 (1.67%) 
General disorders           
Fatigue  1  4/515 (0.78%)  5/210 (2.38%)  8/209 (3.83%)  6/189 (3.17%)  8/180 (4.44%) 
Hepatobiliary disorders           
Blood bilirubin increased  1  40/515 (7.77%)  20/210 (9.52%)  22/209 (10.53%)  22/189 (11.64%)  24/180 (13.33%) 
Hyperbilirubinaemia  1  30/515 (5.83%)  14/210 (6.67%)  20/209 (9.57%)  14/189 (7.41%)  20/180 (11.11%) 
Infections and infestations           
Sinusitis  1  21/515 (4.08%)  15/210 (7.14%)  19/209 (9.09%)  19/189 (10.05%)  25/180 (13.89%) 
Bronchitis  1  18/515 (3.50%)  11/210 (5.24%)  22/209 (10.53%)  20/189 (10.58%)  22/180 (12.22%) 
Upper respiratory tract infection  1  16/515 (3.11%)  13/210 (6.19%)  16/209 (7.66%)  20/189 (10.58%)  19/180 (10.56%) 
Syphilis  1  7/515 (1.36%)  5/210 (2.38%)  7/209 (3.35%)  12/189 (6.35%)  10/180 (5.56%) 
Cellulitis  1  5/515 (0.97%)  6/210 (2.86%)  3/209 (1.44%)  9/189 (4.76%)  3/180 (1.67%) 
Influenza  1  9/515 (1.75%)  6/210 (2.86%)  4/209 (1.91%)  6/189 (3.17%)  6/180 (3.33%) 
Nasopharyngitis  1  7/515 (1.36%)  2/210 (0.95%)  6/209 (2.87%)  2/189 (1.06%)  8/180 (4.44%) 
Pneumonia  1  4/515 (0.78%)  0/210 (0.00%)  4/209 (1.91%)  1/189 (0.53%)  6/180 (3.33%) 
Investigations           
Blood Cholesterol increased  1  8/515 (1.55%)  7/210 (3.33%)  7/209 (3.35%)  8/189 (4.23%)  7/180 (3.89%) 
Lipase increased  1  4/515 (0.78%)  8/210 (3.81%)  1/209 (0.48%)  9/189 (4.76%)  1/180 (0.56%) 
Blood triglycerides increased  1  8/515 (1.55%)  4/210 (1.90%)  4/209 (1.91%)  6/189 (3.17%)  6/180 (3.33%) 
Low density lipoprotein increased  1  4/515 (0.78%)  4/210 (1.90%)  3/209 (1.44%)  6/189 (3.17%)  2/180 (1.11%) 
Metabolism and nutrition disorders           
Hyperlipidaemia  1  5/515 (0.97%)  4/210 (1.90%)  4/209 (1.91%)  3/189 (1.59%)  8/180 (4.44%) 
Hypercholesterolaemia  1  6/515 (1.17%)  5/210 (2.38%)  1/209 (0.48%)  6/189 (3.17%)  1/180 (0.56%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  5/515 (0.97%)  7/210 (3.33%)  0/209 (0.00%)  11/189 (5.82%)  3/180 (1.67%) 
Pain in extremity  1  6/515 (1.17%)  3/210 (1.43%)  3/209 (1.44%)  8/189 (4.23%)  6/180 (3.33%) 
Back pain  1  10/515 (1.94%)  6/210 (2.86%)  3/209 (1.44%)  8/189 (4.23%)  5/180 (2.78%) 
Nervous system disorders           
Headache  1  16/515 (3.11%)  10/210 (4.76%)  10/209 (4.78%)  9/189 (4.76%)  9/180 (5.00%) 
Psychiatric disorders           
Depression  1  18/515 (3.50%)  11/210 (5.24%)  10/209 (4.78%)  11/189 (5.82%)  15/180 (8.33%) 
Insomnia  1  17/515 (3.30%)  6/210 (2.86%)  11/209 (5.26%)  11/189 (5.82%)  13/180 (7.22%) 
Anxiety  1  12/515 (2.33%)  9/210 (4.29%)  8/209 (3.83%)  10/189 (5.29%)  7/180 (3.89%) 
Skin and subcutaneous tissue disorders           
Rash  1  23/515 (4.47%)  10/210 (4.76%)  7/209 (3.35%)  10/189 (5.29%)  7/180 (3.89%) 
Vascular disorders           
Hypertension  1  1/515 (0.19%)  1/210 (0.48%)  4/209 (1.91%)  2/189 (1.06%)  8/180 (4.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: ViiV Healthcare
Phone: 866-435-7343
Publications:
L Ross, E Dejesus, M Potter, A LaMarca, D Murphy, I Melendez-Rivera, D Ward, P Wannamaker, J Uy, L Patel, H Amrine-Madsen, J Horton. Epidemiological and Genotypic Clustering of HIV infection within North America During 2007 International HIV & Hepatitis Drug Resistance Workshop & Curative Strategies, 8-12 June 2010, Dubrovnik, Croatia, Poster 150.
• L Ross, K Squires, B Young, E DeJesus, N Bellos, D Murphy, A Rachlis, H Zhao, L Patel, L Ross, P Wannamaker, M Shaefer. Genotypic Screening Impact in ARIES [Atazanavir (ATV) + Ritonavir (/r) + Abacavir/Lamivudine (ABC/3TC) for 36 Weeks Followed By Randomization to ATV +ABC/3TC or ATV/r + ABC/3TC for 48 Wks in HIV-infected, ART Naïve Patients] :Low Rates of Virologic Failure. The 19th Annual Canadian Conference on HIV/AIDS Research, 13-16 May 2010, Saskatoon, Canada. Poster P-169.
K Squires, E DeJesus, N Bellos, D Ward, D Murphy, H Zhao, L Patel, L Ross, P Wannamaker, M Shaefer. Sustained Virologic Efficacy of Atazanavir (ATV) Versus Atazanavir/Ritonavir (ATV/r), each in Combination with Abacavir/Lamivudine (ABC/3TC) over 120 Weeks: the ARIES Trial. 48th ICAAC; September 12-15, 2010, Boston, MA. Poster H-204.
K Squires, B Young, E DeJesus, N Bellos, D Murphy, D Sutherland-Phillips, H Zhao, L Patel, L Ross, P Wannamaker, M Shaefer. Atazanavir/Ritonavir (ATV/r) + Abacavir/Lamivudine (ABC/3TC) in Antiretroviral (ART)-Naive HIV-1 Infected HLA-B*5701 Negative Subjects Demonstrates Efficacy and Safety: the ARIES Trial. 48th ICAAC; October 25-28, 2008, Washington, DC. Poster H-1250a.
K Squires, B Young, E DeJesus, N Bellos, D Murphy, D Sutherland-Phillips, H Zhao, L Patel, L Ross, P Wannamaker, M Shaefer. Similar Efficacy and Tolerability of Atazanavir (ATV) Compared to ATV/Ritonavir (RTV, r), Each in Combination with Abacavir/Lamivudine (ABC/3TC), after Initial Suppression with ABC/3TC + ATV/r in HIV-1 Infected Patients: 84 Week Results of the ARIES Trial. 5th IAS Conference; Cape Town, South Africa. Abstract WELBB103
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00440947     History of Changes
Other Study ID Numbers: EPZ108859
First Submitted: February 23, 2007
First Posted: February 27, 2007
Results First Submitted: May 19, 2011
Results First Posted: August 17, 2011
Last Update Posted: March 22, 2012