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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
History of Changes
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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  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 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48   [ Time Frame: Week 48 ]
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3.  Secondary:   Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96   [ Time Frame: Week 96 ]
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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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96   [ Time Frame: Weeks 48 and 96 ]
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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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

9.  Secondary:   Median Change From Baseline in HIV-1 RNA at Week 48 and 96   [ Time Frame: Weeks 48 and 96 ]
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10.  Secondary:   Median Change From Baseline in CD4+ Cells at Weeks 48 and 96   [ Time Frame: Weeks 48 and 96 ]
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11.  Secondary:   Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96   [ Time Frame: Baseline to Week 96 ]
  Show Outcome Measure 11

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) ]
  Show Outcome Measure 12

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) ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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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.


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
No text entered.  


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