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

Phase 4

Completed

• Conditions: HIV Infection
• Interventions: Drug: abacavir/lamivudine; Drug: emtricitabine/tenofovir

• Registration Number: NCT00244712
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA (lopinavir/ritonavir) over 96 weeks

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-27
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-23
• Results First Submitted QC: 2009-08-07
• Results First Posted: 2009-09-15
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-03
• Last Update Posted: 2010-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 688

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABC/3TC	abacavir/lamivudine	The intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo +lopinavir/ritonavir.
TDF/FTC	emtricitabine/tenofovir	The intervention is a regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48	Week 48	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).
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96	Week 96	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).
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	Weeks 48 and 96	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.
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	Weeks 48 and 96	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.
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96	Weeks 48 and 96	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).
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	Weeks 48 and 96	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.
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	Weeks 48 and 96	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.
Median Change From Baseline in HIV-1 RNA at Week 48 and 96	Weeks 48 and 96	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.
Median Change From Baseline in CD4+ Cells at Weeks 48 and 96	Weeks 48 and 96	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.
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96	Baseline to Week 96	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.
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks	Baseline and time of virologic failure (up to Week 96)	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.
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility	Baseline and time of virologic failure (up to Week 96)	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.
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction	Baseline through 96 weeks	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇷 San Juan, Puerto Rico