Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone
- Conditions
- HIV
- Interventions
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
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 Change from baseline in CD4 cell count Baseline (Week 0) and at week 48 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 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 Proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 by baseline M184V presence or absence Week 48
Trial Locations
- Locations (12)
Anthony M. Mills Md Inc
🇺🇸Los Angeles, California, United States
Metropolis Medical Pc
🇺🇸San Francisco, California, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
Saint Michael'S Medical Center
🇺🇸Newark, New Jersey, United States
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States
Uc Davis Medical Center
🇺🇸Sacramento, California, United States
Southampton Health Center
🇺🇸Saint Louis, Missouri, United States
James J Peters VAMC
🇺🇸Bronx, New York, United States
Infectious Disease Clinic & AI
🇺🇸Bronx, New York, United States
Southwest Center For Hiv/Aids
🇺🇸Phoenix, Arizona, United States
Health For Life Clinic Pllc
🇺🇸Little Rock, Arkansas, United States
I.D. Care Associates
🇺🇸Hillsborough, New Jersey, United States