Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC

Phase 3

Terminated

• Conditions: HIV
• Interventions: Drug: Atazanavir; Drug: Ritonavir; Drug: Tenofovir/Emtricitabine; Drug: Lamivudine

• Registration Number: NCT01620944
• Lead Sponsor: Bristol-Myers Squibb

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 \[Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-15
• Study Start: 2012-07-31
• Primary Completion: 2013-01-22
• Study Completion: 2013-01-22
• Results First Submitted: 2021-06-03
• Results First Submitted QC: 2021-07-15
• Results First Posted: 2021-08-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm2: ATV/RTVHS+TDF/FTC	Tenofovir/Emtricitabine	-
Arm2: ATV/RTVHS+TDF/FTC	Atazanavir	-
Arm1: ATV/RTVHS+3TC	Atazanavir	-
Arm1: ATV/RTVHS+3TC	Ritonavir	-
Arm1: ATV/RTVHS+3TC	Lamivudine	-
Arm2: ATV/RTVHS+TDF/FTC	Ritonavir	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With HIV-1 RNA < 40 c/mL at Week 48	Week 48	Proportion of subjects with HIV-1 RNA \< 40 c/mL at Week 48.

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events Through Weeks 48 and 96	through weeks 48 and 96	Incidence of Adverse Events through weeks 48 and 96 including serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation.; There were no SAEs or AEs reported in this early terminated study.
Proportion of Participants With HIV-1 RNA < 40 c/mL and < 400 c/mL at Week 96	Week 96	proportion of subjects with HIV-1 RNA \< 40 c/mL and \< 400 c/mL at Week 96.
Proportion of Participants With HIV-1 RNA < 400 c/mL at Week 48	Week 48	Proportion of Participants with HIV-1 RNA \< 400 c/mL at 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	Incidence of newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failures through Week 48 and 96.
Percent Change From Baseline in eGFR and Bone Mineral Density at Weeks 48 and 96	Weeks 48 and 96	Percent change from baseline in eGFR and bone mineral density at weeks 48 and 96.