Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV (HEAT)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00244712
First received: October 25, 2005
Last updated: June 3, 2010
Last verified: June 2010
Results First Received: April 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: emtricitabine/tenofovir
Drug: abacavir/lamivudine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at 76 study sites in the US and 2 study sites in Puerto Rico between 26 July 2005 and 16 June 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After screening, participants who had never received treatment for HIV-1 infection and had a viral load greater than or equal to 1,000 copies per milliliter of blood and any amount of CD4+ T-cells were equally randomized to 1 of 2 treatment groups.

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Participant Flow:   Overall Study
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
STARTED     343     345  
COMPLETED     234     221  
NOT COMPLETED     109     124  
Adverse Event                 20                 21  
Protocol-Defined Virologic Failure                 8                 6  
Lack of Compliance                 10                 11  
Lost to Follow-up                 45                 52  
Withdrawal by Subject                 13                 23  
Protocol Violation, disease progression                 13                 11  



  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
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Total Total of all reporting groups

Baseline Measures
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV     Total  
Number of Participants  
[units: participants]
  343     345     688  
Age  
[units: years]
Mean ± Standard Deviation
  38.0  ± 9.80     38.7  ± 9.55     38.3  ± 9.68  
Gender  
[units: participants]
     
Female     56     69     125  
Male     287     276     563  
Race/Ethnicity, Customized  
[units: participants]
     
African American/African Heritage     122     124     246  
American Indian or Alaskan Native     0     1     1  
Asian     6     9     15  
White     177     174     351  
Mixed Race     2     1     3  
Unspecified     36     36     72  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     73     62     135  
Not Hispanic or Latino     270     282     552  
Missing Information     0     1     1  
Baseline CD4+ Cell Count Level  
[units: participants]
     
<50 cells per cmm     61     70     131  
50 - <200 cells per cmm     99     110     209  
>= 200 cells per cmm     183     165     348  
Baseline HIV-1 RNA Level  
[units: participants]
     
<100,000 copies/mL     188     205     393  
100,000 - <250,000 copies/mL     68     75     143  
250,000 - <500,000 copies/mL     37     33     70  
>=500,000 copies/mL     50     32     82  
Centers for Disease Control (CDC) Classification [1]
[units: participants]
     
A: Asymptomatic HIV infection     229     240     469  
B: Symptomatic HIV infection     59     48     107  
C: AIDS     55     57     112  
Hepatitis B Infection  
[units: participants]
     
Reactive     19     9     28  
Non-Reactive     324     334     658  
Missing     0     2     2  
Hepatitis C Infection  
[units: participants]
     
Reactive     27     24     51  
Non-Reactive     316     319     635  
Missing     0     2     2  
Baseline CD4+ Cell Count  
[units: cells per cmm]
Median ( Full Range )
  214  
  ( 19 to 962 )  
  193  
  ( 19 to 953 )  
  202  
  ( 19 to 962 )  
Baseline HIV-1 RNA [2]
[units: log10 copies/mL]
Median ( Full Range )
  4.903  
  ( 2.658 to 6.994 )  
  4.844  
  ( 1.690 to 6.565 )  
  4.876  
  ( 1.690 to 6.994 )  
[1] HIV, Human Immunodeficiency Virus; AIDS, Acquired Immunodeficiency Syndrome
[2] HIV-1 RNA, Human Immunodeficiency Virus type 1 Ribonucleic acid



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
Measure Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL).
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.
The Intent-To-Treat-Exposed (ITT-E) population which included all randomized participants that had received at least one dose of study medication. In the missing=failure, switched included analysis, participants who had switched their randomized treatment for other treatment were considered as failures, i.e., HIV-1 RNA >=50 copies/mL.

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  343     345  
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.  
[units: percentage of participants]
  67.5     67.2  


Statistical Analysis 1 for Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Cochran-Mantel-Haenszel
P Value [4] 0.913
difference in response percentage [5] 0.39
95% Confidence Interval ( -6.63 to 7.40 )
[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 of the ABC/3TC to the TDF/FTC would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 [ABC/3TC minus TDF/FTC] 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:
  No text entered.
[5] Other relevant estimation information:
  Difference in response percentage = percentage in Arm 1 minus percentage in Arm 2



2.  Secondary:   Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Measure Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
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.
The Intent-To-Treat-Exposed (ITT-E) population which included all patients that had received at least one dose of study medication. The secondary analysis methods were time to loss of virologic response (TLOVR), Observed (Obs), and missing/discontinuation=failure (M/D=F) analyses.

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  343     345  
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48  
[units: percentage of participants]
   
TLOVR     62.6     61.1  
Obs     84.3     86.8  
M/D=F     64.3     62.3  

No statistical analysis provided for Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48



3.  Secondary:   Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Measure Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Time Frame Week 96  
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.
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F.

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  343     345  
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96  
[units: percentage of participants]
   
M=F, Switch Included     59.9     58.0  
TLOVR     52.1     51.0  
Obs     86.9     91.3  
M/D=F     56.4     54.5  

No statistical analysis provided for Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96



4.  Secondary:   Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL   [ Time Frame: Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Measure Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.
Time Frame Weeks 48 and 96  
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.
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  188     205  
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL  
[units: percentage of participants]
   
M=F, Switch Included, Week 48     71     69  
TLOVR, Week 48     67     62  
Obs, Week 48     89     88  
MD=F, Week 48     68     62  
M=F, Switch Included, Week 96     63     58  
TLOVR, Week 96     57     52  
Obs, Week 96     89     94  
MD=F, Week 96     59     54  

No statistical analysis provided for Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL



5.  Secondary:   Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL   [ Time Frame: Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Measure Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.
Time Frame Weeks 48 and 96  
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.
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  155     140  
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL  
[units: percentage of participants]
   
M=F, Switch Included, Week 48     63     65  
TLOVR, Week 48     57     60  
Obs, Week 48     78     86  
M/D=F, Week 48     59     62  
M=F, Switch Included, Week 96     56     58  
TLOVR, Week 96     46     51  
Obs, Week 96     84     88  
M/D=F, Week 96     54     55  

No statistical analysis provided for Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL



6.  Secondary:   Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96   [ Time Frame: Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
Measure Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Time Frame Weeks 48 and 96  
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.
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  343     345  
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96  
[units: percentage of participants]
   
M=F, Switch Included, Week 48     75.2     71.3  
TLOVR, Week 48     70.9     66.4  
Obs, Week 48     93.8     92.2  
M/D=F, Week 48     71.4     66.2  
M=F, Switch Included, Week 96     63.9     61.2  
TLOVR, Week 96     58.4     56.3  
Obs, Week 96     92.8     96.3  
M/D=F, Week 96     60.1     56.9  

No statistical analysis provided for Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96



7.  Secondary:   Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL   [ Time Frame: Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Measure Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.
Time Frame Weeks 48 and 96  
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.
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  188     205  
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL  
[units: percentage of participants]
   
M=F, Switch Included, Week 48     76     71  
TLOVR, Week 48     72     66  
Obs, Week 48     94     91  
M/D=F, Week 48     72     65  
M=F, Switch Included, Week 96     65     60  
TLOVR, Week 96     60     55  
Obs, Week 96     92     97  
M/D=F, Week 96     61     56  

No statistical analysis provided for Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL



8.  Secondary:   Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL   [ Time Frame: Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Measure Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.
Time Frame Weeks 48 and 96  
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.
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  155     140  
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL  
[units: percentage of participants]
   
M=F, Switch Included, Week 48     75     71  
TLOVR, Week 48     70     67  
Obs, Week 48     94     94  
M/D=F, Week 48     71     68  
M=F, Switch Included, Week 96     63     63  
TLOVR, Week 96     56     58  
Obs, Week 96     93     96  
M/D=F, Week 96     59     58  

No statistical analysis provided for Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL



9.  Secondary:   Median Change From Baseline in HIV-1 RNA at Week 48 and 96   [ Time Frame: Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Median Change From Baseline in HIV-1 RNA at Week 48 and 96
Measure Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.
Time Frame Weeks 48 and 96  
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.
The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  236     219  
Median Change From Baseline in HIV-1 RNA at Week 48 and 96  
[units: log10 copies/mL]
Median ( Full Range )
   
Week 48     -3.142  
  ( -4.847 to 0.970 )  
  -3.131  
  ( -4.874 to 2.530 )  
Week 96     -3.114  
  ( -5.304 to 0.819 )  
  -3.165  
  ( -4.874 to 0.139 )  

No statistical analysis provided for Median Change From Baseline in HIV-1 RNA at Week 48 and 96



10.  Secondary:   Median Change From Baseline in CD4+ Cells at Weeks 48 and 96   [ Time Frame: Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
Measure Description A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.
Time Frame Weeks 48 and 96  
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.
The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  234     218  
Median Change From Baseline in CD4+ Cells at Weeks 48 and 96  
[units: cells per cmm]
Median ( Full Range )
   
Week 48     201.0  
  ( -170 to 903 )  
  173.0  
  ( -190 to 921 )  
Week 96     250.0  
  ( -226 to 1033 )  
  246.5  
  ( -116 to 793 )  

No statistical analysis provided for Median Change From Baseline in CD4+ Cells at Weeks 48 and 96



11.  Secondary:   Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
Measure Description The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions.
Time Frame Baseline to Week 96  
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.
The Intent-To-Treat-Exposed (ITT-E) population

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  343     345  
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96  
[units: participants]
   
Protocol-defined virologic failure     49     48  
Fail to confirm HIV-1 RNA <200 copies/mL by wk 24     21     24  
Confirmed HIV-1 RNA rebound to >= 200 copies/mL     28     24  
Suspected HIV-1 RNA rebound to >= 200 copies/mL     12     11  

No statistical analysis provided for Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96



12.  Secondary:   Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks   [ Time Frame: Baseline and time of virologic failure (up to Week 96) ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
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 mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time Frame Baseline and time of virologic failure (up to Week 96)  
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 Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  45     41  
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks  
[units: participants]
   
No. with paired genotypes at baseline and wk 96     45     41  
Participants with treatment-emergent mutations     18     22  
NRTI-associated mutations     11     17  
NNRTI-associated mutations     4     3  
PI-associated mutations     11     7  

No statistical analysis provided for Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks



13.  Secondary:   Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility   [ Time Frame: Baseline and time of virologic failure (up to Week 96) ]

Measure Type Secondary
Measure Title Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Measure Description A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.
Time Frame Baseline and time of virologic failure (up to Week 96)  
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 Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria and had the M184 mutations.

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  11     17  
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility  
[units: participants]
   
Resistance NRTI class (M184V, M/V,M/I,A/V,I,M/I/V)     11     17  
Reduced pheno susceptibility to lamivudine/M184V     4     9  
Reduced phen susceptibility to lamivudine/M184M/V     3     0  
Reduced pheno susceptibility to lamivudine/M184M/I     0     1  
Reduced pheno susceptibility to lamivudine/M184A/V     0     1  
Reduced pheno susceptibility to lamivudine/M184I     0     1  
Reduced pheno suscept. to lamivudine/M184M/I/V     0     1  
Reduced pheno suscept. to emtricitabine/M184V     4     9  
Reduced pheno suscept. to emtricitabine/M184M/V     3     0  
Reduced pheno suscept. to emtricitabine/M184M/I     0     1  
Reduced pheno suscept. to emtricitabine/M184A/V     0     1  
Reduced pheno suscept. to emtricitabine/M184I     0     1  
Reduced pheno suscept. to emtricitabine/M184M/I/V     0     1  

No statistical analysis provided for Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility



14.  Secondary:   Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction   [ Time Frame: Baseline through 96 weeks ]

Measure Type Secondary
Measure Title Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Measure Description The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.
Time Frame Baseline through 96 weeks  
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.
The Safety population which included all randomized participants who received at least one dose of study medication.

Reporting Groups
  Description
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily

Measured Values
    Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)     Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV  
Number of Participants Analyzed  
[units: participants]
  343     345  
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction  
[units: participants]
   
Participants (Par.) with suspected ABC HSR     14     3  
Mild or Grade 1     1     0  
Moderate or Grade 2     8     2  
Severe or Grade 3     4     1  
Not Applicable     1     0  
Par. with proximal renal tubule dysfunction     0     5  

No statistical analysis provided for Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction




  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
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