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An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
Allocation: Randomized nonstratified Intervention model: Parallel versus comparator
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Health For Life Clinic Pllc
Little Rock, Arkansas, United States
Eisenhower Medical Center
Palm Springs, California, United States
Metropolis Medical Pc
San Francisco, California, United States
Consultive Medicine
Daytona Beach, Florida, United States
Orange County Health Dept.
Orlando, Florida, United States
Triple O Medical Services, P.A.
West Palm Beach, Florida, United States
The Research Institute
Springfield, Massachusetts, United States
Aids Care
Rochester, New York, United States
Local Institution
Paris, Cedex 12, France
Local Institution
Lyon, France
Start Date
October 1, 2011
Primary Completion Date
September 1, 2013
Completion Date
February 1, 2014
Last Updated
February 19, 2015
132
ACTUAL participants
Atazanavir
DRUG
Ritonavir (heat-stable)
DRUG
Raltegravir
DRUG
Tenofovir/Emtricitabine
DRUG
Lead Sponsor
Bristol-Myers Squibb
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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