NCT01620944
Terminated
Phase 3
A 48-Week, Randomized, Open-Label Phase 3B Study Comparing the Antiviral Efficacy and Safety of ATV/RTV 3TC With ATV/RTV Plus TDF/FTC In HIV-1-Infected, Treatment-Naïve Subjects, Followed By a 48-Week Period on ATV/RTV Plus 3TC
ConditionsHIV
Overview
- Phase
- Phase 3
- Intervention
- Atazanavir
- Conditions
- HIV
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 3
- Primary Endpoint
- Proportion of Participants With HIV-1 RNA < 40 c/mL at Week 48
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either one additional drug [Lamivudine (3TC) 300 mg daily] or 2 additional drugs [Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily].
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm1: ATV/RTVHS+3TC
Intervention: Atazanavir
Arm1: ATV/RTVHS+3TC
Intervention: Ritonavir
Arm1: ATV/RTVHS+3TC
Intervention: Lamivudine
Arm2: ATV/RTVHS+TDF/FTC
Intervention: Atazanavir
Arm2: ATV/RTVHS+TDF/FTC
Intervention: Ritonavir
Arm2: ATV/RTVHS+TDF/FTC
Intervention: Tenofovir/Emtricitabine
Outcomes
Primary Outcomes
Proportion of Participants With HIV-1 RNA < 40 c/mL at Week 48
Time Frame: Week 48
Proportion of subjects with HIV-1 RNA \< 40 c/mL at Week 48.
Secondary Outcomes
- Incidence of Adverse Events Through Weeks 48 and 96(through weeks 48 and 96)
- Proportion of Participants With HIV-1 RNA < 40 c/mL and < 400 c/mL at Week 96(Week 96)
- Proportion of Participants With HIV-1 RNA < 400 c/mL at Week 48(Week 48)
- Incidence of Newly Emergent Genotypic Substitutions and Phenotypic Resistance to Study Drugs for Virologic Failures Through Week 48 and 96(Through week 48 and 96)
- Percent Change From Baseline in eGFR and Bone Mineral Density at Weeks 48 and 96(Weeks 48 and 96)
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