Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone

Phase 3

Withdrawn

• Conditions: HIV
• Interventions: Drug: Darunavir; Drug: Atazanavir; Drug: Ritonavir; Drug: Optimized NRTI backbone

• Registration Number: NCT01605084
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine the proportion of subjects with HIV-1 RNA \< 50 c/mL at Week 48 in patients who failed their first line therapy containing a non-nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor

Detailed Description

Allocation: Randomization will be stratified

* ATV = Atazanavir

* DRV = Darunavir

* RTV = Ritonavir

Study Timeline

• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-24
• Study Start: 2012-06-30
• Primary Completion: 2014-08-31
• Study Completion: 2014-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: ATV/RTV 300/100 mg QD + optimized NRTI backbone	Optimized NRTI backbone	-
Arm 2: DRV/RTV 800/100 mg QD + optimized NRTI backbone	Optimized NRTI backbone	-
Arm 2: DRV/RTV 800/100 mg QD + optimized NRTI backbone	Ritonavir	-
Arm 2: DRV/RTV 800/100 mg QD + optimized NRTI backbone	Darunavir	-
Arm 1: ATV/RTV 300/100 mg QD + optimized NRTI backbone	Atazanavir	-
Arm 1: ATV/RTV 300/100 mg QD + optimized NRTI backbone	Ritonavir	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL	At Week 48

Secondary Outcome Measures

Name	Time	Method
Incidence rates of serious adverse event (SAEs) and adverse events (AEs) leading to discontinuation	up to week 48
Proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 by baseline M184V presence or absence	Week 48
Change from baseline in CD4 cell count	Baseline (Week 0) and at week 48
Proportion of subjects with HIV-1 RNA < 50 c/mL	At week 24
Incidence rates of antiretroviral resistance measured by newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failure	up to week 48

Trial Locations

Locations (12)

Southwest Center For Hiv/Aids; 🇺🇸 Phoenix, Arizona, United States

Health For Life Clinic Pllc; 🇺🇸 Little Rock, Arkansas, United States

Anthony M. Mills Md Inc; 🇺🇸 Los Angeles, California, United States

Uc Davis Medical Center; 🇺🇸 Sacramento, California, United States

Metropolis Medical Pc; 🇺🇸 San Francisco, California, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Be Well Medical Center; 🇺🇸 Berkley, Michigan, United States

Southampton Health Center; 🇺🇸 Saint Louis, Missouri, United States

I.D. Care Associates; 🇺🇸 Hillsborough, New Jersey, United States

Saint Michael'S Medical Center; 🇺🇸 Newark, New Jersey, United States

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