Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01102972
First received: April 8, 2010
Last updated: October 24, 2013
Last verified: September 2013
Results First Received: November 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: Reyataz + Norvir + Truvada
Drug: Reyataz + Epzicom

  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 from 44 centers in the United States, including Puerto Rico. ATV, atazanavir; RTV, ritonavir; TDF, tenofovir; FTC, emtricitrabine; QD, once daily; HIV-RNA, human immunodeficiency virus-ribonucleic acid; c, copies; ml, milliliters; ART, antiretroviral; mg, milligrams, ABC/3TC, abacavir sulfate/lamivudine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
HLA-B*5701-negative PAR receiving an ATV/RTV + TDF/FTC regimen QD who are virologically suppressed (plasma HIV-1 RNA <75 c/mL) and met all eligibility requirements were randomized 2:1 to receive an ART regimen of ATV 400 mg QD + ABC/3TC 600 mg/300 mg QD (simplification arm) or ATV/RTV 300 mg/100 mg QD + TDF/FTC 300 mg/200 mg QD (continuation arm).

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Participant Flow:   Overall Study
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
STARTED     199 [1]   97 [1]
Completed Week 24     180     88  
COMPLETED     170 [2]   83 [2]
NOT COMPLETED     29     14  
Adverse Event                 8                 2  
Lack of Efficacy                 2                 1  
Protocol Violation                 1                 0  
Lost to Follow-up                 10                 5  
Investigator Discretion                 2                 0  
Withdrawal by Subject                 6                 6  
[1] 297 PAR enrolled. 1 PAR withdrew before taking investigational product and didn’t “start” the study.
[2] These participants completed Study Week 48.



  Baseline Characteristics
  Hide Baseline Characteristics

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 Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
Total Total of all reporting groups

Baseline Measures
    ABC/3TC + ATV     TDF/FTC + ATV/RTV     Total  
Number of Participants  
[units: participants]
  199     97     296  
Age  
[units: Years]
Mean ± Standard Deviation
  42.8  ± 9.54     42.3  ± 10.20     42.6  ± 9.74  
Gender  
[units: Participants]
     
Female     44     18     62  
Male     155     79     234  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     51     26     77  
Not Hispanic or Latino     148     71     219  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
     
African American/African Heritage     65     37     102  
American Indian or Alaskan Native     3     0     3  
Asian - East Asian Heritage     2     0     2  
Asian - South East Asian Heritage     4     1     5  
Native Hawaiian or Other Pacific Islander     0     1     1  
White - Arabic/North African Heritage     2     0     2  
White - White/Caucasian/European Heritage     120     55     175  
Mixed Race     3     3     6  
Number of participants with the indicated baseline HIV-RNA level [1]
[units: participants]
     
HIV-1 RNA <50     192     93     285  
HIV-1 RNA 50-<75     2     2     4  
HIV-1 RNA >=75     5     2     7  
Number of participants with the indicated Baseline CD4+ Cell Count [2]
[units: participants]
     
CD4+ cells <50     0     0     0  
CD4+ cells 50-<200     14     6     20  
CD4+ cells >=200     185     91     276  
Number of participants with the indicated Center for Disease Control (CDC) Classification [3]
[units: participants]
     
Class A: Asymptomatic/lymphadenopathy/acute HIV     136     67     203  
Class B: Symptomatic, not AIDS     26     13     39  
Class C: AIDS indicator conditions     37     17     54  
Median Baseline CD4+ Cell Count  
[units: cells per cubic millimeter]
Median ( Full Range )
  492.0  
  ( 77.0 to 1196.0 )  
  480.0  
  ( 108.0 to 1479.0 )  
  491.5  
  ( 77.0 to 1479.0 )  
Median Baseline HIV-1 RNA Level  
[units: log10 copies/mL]
Median ( Full Range )
  1.591  
  ( 1.591 to 3.900 )  
  1.591  
  ( 1.591 to 3.285 )  
  1.591  
  ( 1.591 to 3.900 )  
Number of participants with the indicated Baseline Hepatitis B (HB) Status [4]
[units: participants]
     
Reactive     0     0     0  
Non-reactive     199     97     296  
Number of participants with the indicated Baseline Hepatitis C (HC) Status [5]
[units: participants]
     
Reactive     18     8     26  
Non-reactive     181     89     270  
[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, measured as the number of cells per cubic millimeter.
[3] Acquired Immunodeficiency Syndrome (AIDS) CDC classifications are Asymptomatic, Symptomatic, or AIDS. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, >=500 cells per microliter [µl]; Class B, 200-499 cells/µl; Class C, <200 cells/µl) and on previously diagnosed HIV-related conditions.
[4] The HB surface antigen is a protein present on the surface of the hepatitis B virus (HBV). It can be detected in the blood of participants with acute and chronic HBV infections. A non-reactive test result likely means that participants are not infected with HB, but does not exclude the possibility of exposure to or infection with HB.
[5] The HC surface antigen is a protein present on the surface of the hepatitis C virus (HCV). It can be detected in the blood of participants with acute and chronic HCV infections. A non-reactive test result likely means that participants are not infected with HC, but does not exclude the possibility of exposure to or infection with HC.



  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 24 Visit: TLOVR Analysis   [ Time Frame: Week 24 ]

Measure Type Primary
Measure Title Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis
Measure Description The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit.
Time Frame Week 24  
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: all participants exposed to at least one dose of study medication. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <50 copies/mL at Week 24.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis  
[units: percentage of participants]
  86.9     86.6  


Statistical Analysis 1 for Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.937
Treatment difference of proportions [5] 0.33
95% Confidence Interval ( -7.97 to 8.64 )
[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) for the difference in the percentage of participants with HIV-1 RNA <50 copies/mL at Week 24 was -12% or greater.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The p-value was obtained from the Cochran-Mantel-Haenszel method stratified by initial antiretroviral regimen.
[5] Other relevant estimation information:
  95% confidence intervals were calculated (using Mantel-Haenszel weight) stratified by initial antiretroviral regimen.



2.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses
Measure Description The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Time Frame Week 24  
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. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses  
[units: percentage of participants]
   
Observed, n=181, 89     94.5     97.7  
M/D=F, n=199, 97     84.9     87.6  
SNAPSHOT, n=199, 97     84.9     88.7  

No statistical analysis provided for Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses



3.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses
Measure Description The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Time Frame Week 48  
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. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses  
[units: Percentage of participants]
   
TLOVR, n=199, 97     76.4     79.4  
Observed, n=169, 82     91.1     96.3  
M/D=F, n=199, 97     76.9     79.4  
SNAPSHOT, n=199, 97     77.4     81.4  

No statistical analysis provided for Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses



4.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis
Measure Description The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.
Time Frame Week 24  
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. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <400 copies/mL at Week 24.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis  
[units: percentage of participants]
  88.4     86.6  

No statistical analysis provided for Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis



5.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis
Measure Description The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.
Time Frame Week 48  
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

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis  
[units: Percentage of participants]
  81     84  

No statistical analysis provided for Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis



6.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses
Measure Description The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Time Frame Week 24  
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. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses  
[units: percentage of participants]
   
Observed, n=181, 89     98.9     98.9  
M/D=F, n=199, 97     88.9     88.7  
SNAPSHOT, n=199, 97     89.4     89.7  

No statistical analysis provided for Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses



7.  Secondary:   Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses
Measure Description The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Time Frame Week 48  
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. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses  
[units: Percentage of participants]
   
Observed, n=169, 82     96     100  
M/D=F, n=199, 97     81     82  
SNAPSHOT, n=199, 97     82     85  

No statistical analysis provided for Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses



8.  Secondary:   Change From Baseline in HIV-1 RNA at Week 24   [ Time Frame: Baseline and Week 24 ]

Measure Type Secondary
Measure Title Change From Baseline in HIV-1 RNA at Week 24
Measure Description Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time Frame Baseline and Week 24  
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. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a viral load result obtained during that visit period.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  181     89  
Change From Baseline in HIV-1 RNA at Week 24  
[units: log10 copies/mL]
Mean ± Standard Deviation
  0.014  ± 0.271     0.008  ± 0.352  

No statistical analysis provided for Change From Baseline in HIV-1 RNA at Week 24



9.  Secondary:   Change From Baseline in HIV-1 RNA at Week 48   [ Time Frame: Baseline and Week 48 ]

Measure Type Secondary
Measure Title Change From Baseline in HIV-1 RNA at Week 48
Measure Description Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time Frame Baseline and Week 48  
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. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a viral load result obtained during that visit period.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  169     82  
Change From Baseline in HIV-1 RNA at Week 48  
[units: log10 copies/mL]
Mean ± Standard Deviation
  0.071  ± 0.448     -0.018  ± 0.198  

No statistical analysis provided for Change From Baseline in HIV-1 RNA at Week 48



10.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 24   [ Time Frame: Baseline and Week 24 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4+ Cell Count at Week 24
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 24 value minus the Baseline value.
Time Frame Baseline and Week 24  
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. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a CD4+ cell count obtained during that visit period.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  181     89  
Change From Baseline in CD4+ Cell Count at Week 24  
[units: cells per cubic millimeter (mm^3)]
Mean ± Standard Deviation
  47.7  ± 134.02     8.3  ± 122.40  

No statistical analysis provided for Change From Baseline in CD4+ Cell Count at Week 24



11.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 48   [ Time Frame: Baseline and Week 48 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4+ Cell Count at Week 48
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 48 value minus the Baseline value.
Time Frame Baseline and Week 48  
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. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a CD4+ cell count obtained during that visit period.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  169     83  
Change From Baseline in CD4+ Cell Count at Week 48  
[units: cells per cubic millimeter (mm^3)]
Mean ± Standard Deviation
  95.8  ± 158.93     57.2  ± 139.84  

No statistical analysis provided for Change From Baseline in CD4+ Cell Count at Week 48



12.  Secondary:   Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24   [ Time Frame: Baseline and Week 24 ]

Measure Type Secondary
Measure Title Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24
Measure Description Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter.
Time Frame Baseline and Week 24  
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.
Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  170     81  
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24  
[units: milligrams per deciliter (mg/dL)]
Mean ± Standard Deviation
   
Triglycerides, n=170, 81     -17.23  ± 62.29     -4.35  ± 63.00  
Total cholesterol, n=170, 81     4.49  ± 26.37     0.14  ± 26.24  
HDL cholesterol, n=170, 81     4.50  ± 8.78     -0.20  ± 8.73  
LDL cholesterol (Calculation), n=166, 80     3.34  ± 22.48     0.94  ± 25.72  

No statistical analysis provided for Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24



13.  Secondary:   Change From Baseline in Cholesterol/HDL Ratio at Week 24   [ Time Frame: Baseline and Week 24 ]

Measure Type Secondary
Measure Title Change From Baseline in Cholesterol/HDL Ratio at Week 24
Measure Description A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value.
Time Frame Baseline and Week 24  
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.
Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  170     81  
Change From Baseline in Cholesterol/HDL Ratio at Week 24  
[units: ratio]
Mean ± Standard Deviation
  -0.20  ± 0.57     -0.01  ± 0.66  

No statistical analysis provided for Change From Baseline in Cholesterol/HDL Ratio at Week 24



14.  Secondary:   Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48   [ Time Frame: Baseline and Week 48 ]

Measure Type Secondary
Measure Title Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48
Measure Description Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.
Time Frame Baseline and Week 48  
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.
Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  152     76  
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48  
[units: milligrams per deciliter (mg/dL)]
Mean ± Standard Deviation
   
Triglycerides, n=152, 76     -9.28  ± 65.39     7.71  ± 91.00  
Total cholesterol, n=152, 76     7.62  ± 31.04     0.62  ± 29.90  
HDL cholesterol, n=152, 76     3.11  ± 9.33     0.53  ± 9.58  
LDL cholesterol (Calculation), n=148, 71     5.28  ± 26.35     -0.62  ± 28.21  

No statistical analysis provided for Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48



15.  Secondary:   Change From Baseline in Cholesterol/HDL Ratio at Week 48   [ Time Frame: Baseline and Week 48 ]

Measure Type Secondary
Measure Title Change From Baseline in Cholesterol/HDL Ratio at Week 48
Measure Description A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.
Time Frame Baseline and Week 48  
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.
Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  152     76  
Change From Baseline in Cholesterol/HDL Ratio at Week 48  
[units: ratio]
Mean ± Standard Deviation
  0.00  ± 0.97     0.00  ± 0.69  

No statistical analysis provided for Change From Baseline in Cholesterol/HDL Ratio at Week 48



16.  Secondary:   Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24   [ Time Frame: From Baseline to Week 24 ]

Measure Type Secondary
Measure Title Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24
Measure Description The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.
Time Frame From Baseline to Week 24  
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

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24  
[units: participants]
  2     1  

No statistical analysis provided for Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24



17.  Secondary:   Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48   [ Time Frame: From Baseline to Week 48 ]

Measure Type Secondary
Measure Title Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48
Measure Description The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.
Time Frame From Baseline to Week 48  
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

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48  
[units: participants]
  4     1  

No statistical analysis provided for Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48



18.  Secondary:   Number of Participants Who Experienced Death and/or Disease Progression   [ Time Frame: From Baseline to Week 48 ]

Measure Type Secondary
Measure Title Number of Participants Who Experienced Death and/or Disease Progression
Measure Description Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, >=500 cells per microliter [µl]; Class B, 200-499 cells/µl; Class C, <200 cells/µl) and on previously diagnosed HIV-related conditions.
Time Frame From Baseline to Week 48  
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

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Number of Participants Who Experienced Death and/or Disease Progression  
[units: participants]
  0     0  

No statistical analysis provided for Number of Participants Who Experienced Death and/or Disease Progression



19.  Secondary:   Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24   [ Time Frame: From Baseline to Week 24 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24
Measure Description A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time Frame From Baseline to Week 24  
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. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  2     1  
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24  
[units: participants]
   
PAR with treatment-emergent mutations     2     1  
PAR with NRTI mutations     1     0  
PAR with NNRTI mutations     1     0  
PAR with major PI mutations     1     0  
PAR with minor PI mutations     2     1  

No statistical analysis provided for Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24



20.  Secondary:   Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48   [ Time Frame: From Baseline to Week 48 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48
Measure Description A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time Frame From Baseline to Week 48  
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. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  4     1  
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48  
[units: participants]
   
PAR with treatment-emergent mutations     4     1  
PAR with NRTI mutations     2     0  
PAR with major NNRTI mutations     1     0  
PAR with major PI mutations     2     0  
PAR with minor PI mutations     4     1  

No statistical analysis provided for Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48



21.  Secondary:   Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir   [ Time Frame: From Baseline to Week 24 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
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.
Time Frame From Baseline to Week 24  
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. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  2     1  
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir  
[units: participants]
   
HIV PAR with reduced abacavir susceptibility     1     0  
HIV PAR with reduced lamivudine susceptibility     1     0  
HIV PAR with reduced tenofovir susceptibility     0     0  
HIV PAR with reduced emtricitabine susceptibility     1     0  
HIV PAR with reduced atazanavir susceptibility     1     0  
HIV PAR with reduced ritonavir susceptibility     1     0  

No statistical analysis provided for Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir



22.  Secondary:   Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir   [ Time Frame: From Baseline to Week 48 ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir
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.
Time Frame From Baseline to Week 48  
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. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  4     1  
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir  
[units: participants]
   
HIV PAR with reduced abacavir susceptibility     1     0  
HIV PAR with reduced lamivudine susceptibility     2     0  
HIV PAR with reduced tenofovir susceptibility     0     0  
HIV PAR with reduced emtricitabine susceptibility     2     0  
HIV PAR with reduced atazanavir susceptibility     2     0  
HIV PAR with reduced ritonavir susceptibility     2     0  

No statistical analysis provided for Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir



23.  Secondary:   Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group   [ Time Frame: From Baseline to Week 24 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Measure Description The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.
Time Frame From Baseline to Week 24  
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.
Safety Population

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group  
[units: participants]
   
Upper respiratory tract infection     7     6  
Diarrhoea     5     3  
Bronchitis     4     3  
Rash     6     0  
Muscle strain     2     3  
Muscle spasms     1     3  
Sinusitis     1     3  

No statistical analysis provided for Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group



24.  Secondary:   Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group   [ Time Frame: From Baseline to Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
Measure Description The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.
Time Frame From Baseline to Week 48  
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.
Safety Population

Reporting Groups
  Description
ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Measured Values
    ABC/3TC + ATV     TDF/FTC + ATV/RTV  
Number of Participants Analyzed  
[units: participants]
  199     97  
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group  
[units: participants]
   
Any Event     90     44  
Upper respiratory tract infection     11     7  
Diarrhoea     7     4  
Depression     6     3  
Back pain     4     3  
Bronchitis     4     3  
Insomnia     6     0  
Muscle strain     3     3  
Rash     6     0  
Sinusitis     2     4  
Muscle spasms     2     3  

No statistical analysis provided for Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
This study consists of a 35-day Screening Period, a 48-week Treatment Period, and a Follow-up Period (contact ~2-4 weeks after the Week 48/Withdrawal Visit). Data from Week 24 (primary endpoint) and Week 48 (final data) are presented in this summary.


  More Information