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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00440947
First received: February 23, 2007
Last updated: March 15, 2012
Last verified: July 2011
Results First Received: May 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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50 copies/ml before Week 36 weren't allowed to randomize at Week 36 and were withdrawn.

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase 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)
ABC/3TC + ATV: Randomization Phase Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD
ABC/3TC + ATV/r: Randomization Phase Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
ABC/3TC + ATV: Extension Phase Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Participant Flow for 3 periods

Period 1:   36-Week Induction Phase
    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  
STARTED     515     0     0     0     0  
COMPLETED     442 [1]   0     0     0     0  
NOT COMPLETED     73     0     0     0     0  
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 2:   48-Week Randomization Phase
    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  
STARTED     0     210     209     0     0  
COMPLETED     0     194     185     0     0  
NOT COMPLETED     0     16     24     0     0  
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 3:   Optional 60-Week Extension Phase
    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  
STARTED     0     0     0     189     180  
COMPLETED     0     0     0     160     154  
NOT COMPLETED     0     0     0     29     26  
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  
Unknown                 0                 0                 0                 1                 0  
Physician Decision                 0                 0                 0                 0                 1  
Participant Remained in Cuba                 0                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ABC/3TC + ATV/r 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)

Baseline Measures
    ABC/3TC + ATV/r  
Number of Participants  
[units: participants]
  515  
Age  
[units: Years]
Mean ± Standard Deviation
  38.3  ± 10.03  
Gender  
[units: Participants]
 
Female     86  
Male     429  
Race/Ethnicity, Customized  
[units: 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]
[units: 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  
Number of participants with the indicated Baseline CD4+ Cell Count [2]
[units: participants]
 
CD4+ cells <50     69  
CD4+ cells 50-<200     190  
CD4+ cells >=200     256  
Number of participants with the indicated Center for Disease Control (CDC) Classification [3]
[units: participants]
 
Asymptomatic HIV Infection     353  
Symptomatic (non-AIDS) condition     97  
AIDS     65  
Median Baseline CD4+ Cell Count  
[units: cells per cubic millimeter]
Median ( Full Range )
  199  
  ( 19 to 754 )  
Median Baseline HIV-1 RNA Level  
[units: log10 copies/ml]
Median ( Full Range )
  5.076  
  ( 2.989 to 6.620 )  
[1] HIV-1 RNA, Human Immunodeficiency Virus type 1 Ribonucleic acid. HIV-1 viral load was measured as virus copies per milliliter (ml) at baseline.
[2] A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts.
[3] AIDS, Acquired Immunodeficiency Syndrome CDC classifications are Asymptomatic, Symptomatic, or AIDs.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit   [ Time Frame: Week 84 ]

Measure Type Primary
Measure Title Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  210     209  
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit  
[units: percentage of participants]
  86     81  


Statistical Analysis 1 for Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.140
Risk Difference (RD) [5] 5.4
95% Confidence Interval ( -1.8 to 12.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  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.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  p-value was obtained from Cochran-Mantel-Haenszel stratified by baseline HIV-1 RNA (<100000/>=100000)
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



2.  Secondary:   Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase   [ Time Frame: Baseline of Randomized Phase ]

Measure Type Secondary
Measure Title Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase
Measure Description The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline.
Time Frame Baseline of Randomized Phase  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population: all participants exposed to at least one dose of study medication during the Randomized Simplification Phase

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  210     209  
Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase  
[units: years]
Mean ± Standard Deviation
  37.5  ± 10.23     39.7  ± 9.71  

No statistical analysis provided for Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase



3.  Secondary:   Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit   [ Time Frame: Week 36 ]

Measure Type Secondary
Measure Title Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population, Induction Phase: all participants exposed to at least one dose of study medication during the Induction Phase of the study

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase 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)

Measured Values
    ABC/3TC + ATV/r: Induction Phase  
Number of Participants Analyzed  
[units: participants]
  515  
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit  
[units: percentage of participants]
 
TLOVR     80  
Obs     88  
M/D=F     77  

No statistical analysis provided for Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit



4.  Secondary:   Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit   [ Time Frame: Week 84 ]

Measure Type Secondary
Measure Title Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population, Randomized Phase. The secondary analysis methods were Observed (Obs) and missing/discontinuation=failure (M/D=F) analyses.

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  210     209  
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit  
[units: percentage of participants]
   
Obs     92     92  
M/D=F     85     82  

No statistical analysis provided for Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit



5.  Secondary:   Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit   [ Time Frame: Week 144 ]

Measure Type Secondary
Measure Title Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-Extension Population, Extension Phase: all participants exposed to at least one dose of study medication during the Extension Phase of the study

Reporting Groups
  Description
ABC/3TC + ATV: Extension Phase Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Extension Phase     ABC/3TC + ATV/r: Extension Phase  
Number of Participants Analyzed  
[units: participants]
  189     180  
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit  
[units: percentage of participants]
   
TLOVR     77     73  
Obs     95     92  
M/D=F     80     78  

No statistical analysis provided for Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit



6.  Secondary:   Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit   [ Time Frame: Week 36 ]

Measure Type Secondary
Measure Title Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population, Induction Phase

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase 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)

Measured Values
    ABC/3TC + ATV/r: Induction Phase  
Number of Participants Analyzed  
[units: participants]
  515  
Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit  
[units: percentage of participants]
 
TLOVR     82  
Obs     98  
M/D=F     84  

No statistical analysis provided for Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit



7.  Secondary:   Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit   [ Time Frame: Week 84 ]

Measure Type Secondary
Measure Title Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population, Randomized Phase

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  210     209  
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit  
[units: percentage of participants]
   
TLOVR     92     86  
Obs     99     98  
M/D=F     92     87  

No statistical analysis provided for Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit



8.  Secondary:   Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit   [ Time Frame: Week 144 ]

Measure Type Secondary
Measure Title Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-Extension Population, Extension Phase

Reporting Groups
  Description
ABC/3TC + ATV: Extension Phase Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Extension Phase     ABC/3TC + ATV/r: Extension Phase  
Number of Participants Analyzed  
[units: participants]
  189     180  
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit  
[units: percentage of participants]
   
TLOVR     84     80  
Obs     99     97  
M/D=F     84     82  

No statistical analysis provided for Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit



9.  Secondary:   Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36   [ Time Frame: Week 36 ]

Measure Type Secondary
Measure Title Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population, Induction Phase

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase 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)

Measured Values
    ABC/3TC + ATV/r: Induction Phase  
Number of Participants Analyzed  
[units: participants]
  515  
Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36  
[units: participants]
 
Protocol-defined virologic failure     15  
Failure to achieve <400 c/ml by Week 30     5  
Confirmed rebound after achieving <400 c/ml     10  

No statistical analysis provided for Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36



10.  Secondary:   Number of Participants Who Met the PDVF Criteria at Week 84   [ Time Frame: Week 84 ]

Measure Type Secondary
Measure Title Number of Participants Who Met the PDVF Criteria at Week 84
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  210     209  
Number of Participants Who Met the PDVF Criteria at Week 84  
[units: participants]
   
Protocol-defined virologic failure     1     7  
Confirmed rebound after achieving <400 c/ml     1     7  

No statistical analysis provided for Number of Participants Who Met the PDVF Criteria at Week 84



11.  Secondary:   Number of Participants Who Met the PDVF Criteria at Week 144   [ Time Frame: Week 144 ]

Measure Type Secondary
Measure Title Number of Participants Who Met the PDVF Criteria at Week 144
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-Extension Population, Extension Phase. TLOVR.

Reporting Groups
  Description
ABC/3TC + ATV: Extension Phase Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Extension Phase     ABC/3TC + ATV/r: Extension Phase  
Number of Participants Analyzed  
[units: participants]
  210     209  
Number of Participants Who Met the PDVF Criteria at Week 144  
[units: participants]
   
Protocol-defined virologic failure     5     6  
Confirmed rebound after achieving <400 c/ml     5     6  

No statistical analysis provided for Number of Participants Who Met the PDVF Criteria at Week 144



12.  Secondary:   Change From Baseline in HIV-1 RNA at Week 36   [ Time Frame: Baseline and Week 36 ]

Measure Type Secondary
Measure Title Change From Baseline in HIV-1 RNA at Week 36
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase 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)

Measured Values
    ABC/3TC + ATV/r: Induction Phase  
Number of Participants Analyzed  
[units: participants]
  447  
Change From Baseline in HIV-1 RNA at Week 36  
[units: log10 c/ml]
Mean ± Standard Deviation
  -3.241  ± 0.775  

No statistical analysis provided for Change From Baseline in HIV-1 RNA at Week 36



13.  Secondary:   Change From Baseline in HIV-1 RNA at Week 84   [ Time Frame: Baseline and Week 84 ]

Measure Type Secondary
Measure Title Change From Baseline in HIV-1 RNA at Week 84
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  194     187  
Change From Baseline in HIV-1 RNA at Week 84  
[units: log10 c/ml]
Mean ± Standard Deviation
  -3.261  ± 0.681     -3.270  ± 0.698  

No statistical analysis provided for Change From Baseline in HIV-1 RNA at Week 84



14.  Secondary:   Change From Baseline in HIV-1 RNA at Week 144   [ Time Frame: Baseline and Week 144 ]

Measure Type Secondary
Measure Title Change From Baseline in HIV-1 RNA at Week 144
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV: Extension Phase Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Extension Phase     ABC/3TC + ATV/r: Extension Phase  
Number of Participants Analyzed  
[units: participants]
  163     154  
Change From Baseline in HIV-1 RNA at Week 144  
[units: log10 c/ml]
Mean ± Standard Deviation
  -3.291  ± 0.675     -3.239  ± 0.835  

No statistical analysis provided for Change From Baseline in HIV-1 RNA at Week 144



15.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 36   [ Time Frame: Baseline and Week 36 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4+ Cell Count at Week 36
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase 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)

Measured Values
    ABC/3TC + ATV/r: Induction Phase  
Number of Participants Analyzed  
[units: participants]
  438  
Change From Baseline in CD4+ Cell Count at Week 36  
[units: cells/millimeters cubed (mm^3)]
Mean ± Standard Deviation
  185.4  ± 121.84  

No statistical analysis provided for Change From Baseline in CD4+ Cell Count at Week 36



16.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 84   [ Time Frame: Baseline and Week 84 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4+ Cell Count at Week 84
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  193     187  
Change From Baseline in CD4+ Cell Count at Week 84  
[units: cells/millimeters cubed (mm^3)]
Mean ± Standard Deviation
  265.7  ± 157.65     282.9  ± 150.49  

No statistical analysis provided for Change From Baseline in CD4+ Cell Count at Week 84



17.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 144   [ Time Frame: Baseline and Week 144 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4+ Cell Count at Week 144
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV: Extension Phase Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Extension Phase     ABC/3TC + ATV/r: Extension Phase  
Number of Participants Analyzed  
[units: participants]
  163     156  
Change From Baseline in CD4+ Cell Count at Week 144  
[units: cells/millimeters cubed (mm^3)]
Mean ± Standard Deviation
  317.7  ± 161.98     325.1  ± 178.29  

No statistical analysis provided for Change From Baseline in CD4+ Cell Count at Week 144



18.  Secondary:   Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36   [ Time Frame: Baseline through Week 36 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase 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)

Measured Values
    ABC/3TC + ATV/r: Induction Phase  
Number of Participants Analyzed  
[units: participants]
  15  
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36  
[units: 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  

No statistical analysis provided for Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36



19.  Secondary:   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   [ Time Frame: Randomization at Week 36 through Week 84 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  1     7  
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  
[units: 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  

No statistical analysis provided for 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



20.  Secondary:   Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144   [ Time Frame: Week 84 through Week 144 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations.

Reporting Groups
  Description
ABC/3TC + ATV: Extension Phase Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Extension Phase     ABC/3TC + ATV/r: Extension Phase  
Number of Participants Analyzed  
[units: participants]
  5     6  
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144  
[units: 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  

No statistical analysis provided for Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144



21.  Secondary:   Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir   [ Time Frame: Baseline through Week 36 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase 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)

Measured Values
    ABC/3TC + ATV/r: Induction Phase  
Number of Participants Analyzed  
[units: participants]
  15  
Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir  
[units: 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  

No statistical analysis provided for Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir



22.  Secondary:   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   [ Time Frame: Randomization at Week 36 through Week 84 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  1     7  
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  
[units: 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  

No statistical analysis provided for 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



23.  Secondary:   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   [ Time Frame: Week 84 through Week 144 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure phenotypic evaluations

Reporting Groups
  Description
ABC/3TC + ATV: Extension Phase Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Extension Phase     ABC/3TC + ATV/r: Extension Phase  
Number of Participants Analyzed  
[units: participants]
  5     6  
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  
[units: 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  

No statistical analysis provided for 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



24.  Secondary:   Mean Percent Compliance at Week 36   [ Time Frame: Week 36 ]

Measure Type Secondary
Measure Title Mean Percent Compliance at Week 36
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV/r: Induction Phase 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)

Measured Values
    ABC/3TC + ATV/r: Induction Phase  
Number of Participants Analyzed  
[units: participants]
  503  
Mean Percent Compliance at Week 36  
[units: percent compliance]
Mean ± Standard Deviation
 
Abacavir/Lamivudine     92.2  ± 13.05  
Ritonavir     92.3  ± 12.15  
Atazanavir     92.7  ± 12.50  

No statistical analysis provided for Mean Percent Compliance at Week 36



25.  Secondary:   Mean Percent Compliance at Week 84   [ Time Frame: Week 84 ]

Measure Type Secondary
Measure Title Mean Percent Compliance at Week 84
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV: Randomized Phase Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
ABC/3TC + ATV/r: Randomized Phase Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Randomized Phase     ABC/3TC + ATV/r: Randomized Phase  
Number of Participants Analyzed  
[units: participants]
  210     209  
Mean Percent Compliance at Week 84  
[units: percent compliance]
Mean ± Standard Deviation
   
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  

No statistical analysis provided for Mean Percent Compliance at Week 84



26.  Secondary:   Mean Percent Compliance at Week 144   [ Time Frame: Week 144 ]

Measure Type Secondary
Measure Title Mean Percent Compliance at Week 144
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC + ATV: Extension Phase Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
ABC/3TC + ATV/r: Extension Phase Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD

Measured Values
    ABC/3TC + ATV: Extension Phase     ABC/3TC + ATV/r: Extension Phase  
Number of Participants Analyzed  
[units: participants]
  189     180  
Mean Percent Compliance at Week 144  
[units: percent compliance]
Mean ± Standard Deviation
   
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  

No statistical analysis provided for Mean Percent Compliance at Week 144




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: ViiV Healthcare
phone: 866-435-7343


Publications:
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

Publications automatically indexed to this study:


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00440947     History of Changes
Other Study ID Numbers: EPZ108859
Study First Received: February 23, 2007
Results First Received: May 19, 2011
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration