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
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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 ]

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

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

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 ]

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

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 ]

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

10.  Secondary:   Median Change From Baseline in CD4+ Cells at Weeks 48 and 96   [ Time Frame: 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 ]
  Hide Outcome Measure 11

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) ]

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) ]

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 ]


  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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  More Information
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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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00244712     History of Changes
Other Study ID Numbers: EPZ104057, 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