Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  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 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
  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
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 
Overall Participants Analyzed 
[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 
[1] HIV, Human Immunodeficiency Virus; AIDS, Acquired Immunodeficiency Syndrome
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 [1] 
[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-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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00244712     History of Changes
Other Study ID Numbers: EPZ104057
Study First Received: October 25, 2005
Results First Received: April 23, 2009
Last Updated: June 3, 2010
Health Authority: United States: Food and Drug Administration