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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
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 
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
  Show 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 ]

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 ]
  Hide Outcome Measure 7

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 ]

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 ]

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


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