A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor
- Conditions
- HIV Infections
- Registration Number
- NCT00028067
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.
- Detailed Description
In this double-blind, double-placebo, randomized, 2-arm study, atazanavir and NFV each are given in combination with 2 open-label nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks. Patients assigned to atazanavir will receive placebo capsules which are identical in size and appearance to NFV. Patients assigned to NFV will receive placebo capsules which are identical in size and appearance to atazanavir. HIV levels are monitored.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
Ramathibodi Hosp
🇹🇭Bangkok, Thailand
Khonkaen Univ
🇹🇭Khonkaen, Thailand
Health for Life Clinic
🇺🇸Little Rock, Arkansas, United States
Downtown Infectious Diseases Clinic
🇨🇦Vancouver, British Columbia, Canada
Clinique Medicale L'Actuele
🇨🇦Montreal, Quebec, Canada
South Jersey Infectious Diseases Inc
🇺🇸Somers Point, New Jersey, United States
Univ of South Carolina School of Medicine
🇺🇸Columbia, South Carolina, United States
Hospital General De Mexico
🇲🇽Mexico City, Mexico
Siriraj Hosp / Mahidol Univ
🇹🇭Bangkok, Thailand
Hepatology / Infectious Diseases
🇵🇷Santruce, Puerto Rico
Program on AIDS / Thai Red Cross Society
🇹🇭Bangkok, Thailand
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Univ TX Health Science Ctr
🇺🇸Houston, Texas, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Tower Infectious Diseases
🇺🇸Los Angeles, California, United States
Bach and Godofsky
🇺🇸Bradenton, Florida, United States
Gary Richmond MD
🇺🇸Fort Lauderdale, Florida, United States
Clinique Medicale du Quartier Latin
🇨🇦Montreal, Quebec, Canada
North Broward Hosp District / HIV Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
North Texas Center for AIDS & Clinical Research
🇺🇸Dallas, Texas, United States
Community Research Initiative on AIDS
🇺🇸New York, New York, United States
Orange County Ctr for Special Immunology
🇺🇸Fountain Valley, California, United States
Hospital Regional
🇲🇽Mexico City, Mexico
Cook County Gen Hosp / Division of Infect Diseases
🇺🇸Chicago, Illinois, United States
Joseph Gathe
🇺🇸Houston, Texas, United States
CRI - Springfield
🇺🇸Springfield, Massachusetts, United States
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
Philip Brachman
🇺🇸Atlanta, Georgia, United States
Univ of Texas Southwestern Med Ctr
🇺🇸Dallas, Texas, United States
Infectious Diseases Associates
🇺🇸Sarasota, Florida, United States
Community Research Initiative of New England
🇺🇸Brookline, Massachusetts, United States
Infectious Disease Clinic
🇺🇸Warren, Michigan, United States
Associates in Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Wake Forest Univ School of Medicine
🇺🇸Winston Salem, North Carolina, United States
McMaster Univ Med Ctr
🇨🇦Hamilton, Ontario, Canada
Hahnemann Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Sunnybrook Health Science Ctr
🇨🇦Toronto, Ontario, Canada
Division of Inf Diseases/ Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
HIV Institute / Davies Med Ctr
🇺🇸San Francisco, California, United States
Research & Education Group
🇺🇸Portland, Oregon, United States
Daniel Seekins
🇺🇸Tampa, Florida, United States
Infectious Disease Research Inst
🇺🇸Tampa, Florida, United States
Wisconsin AIDS Research Consortium
🇺🇸Milwaukee, Wisconsin, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Washington Univ School of Medicine
🇺🇸St Louis, Missouri, United States
Larry Bush
🇺🇸Atlantis, Florida, United States
Piedmont Infectious Disease Consultants
🇺🇸Hickory, North Carolina, United States
Ponce School of Medicine
🇵🇷Ponce, Puerto Rico
Instituto Nacional de Enfermedades Respiratorias
🇲🇽Mexico City, Mexico
Instituto Nacional de la Nutricion
🇲🇽Mexico City, Mexico
Summa Health System
🇺🇸Akron, Ohio, United States
Jemsek Clinic
🇺🇸Huntersville, North Carolina, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Kaiser Hospital
🇺🇸Sacramento, California, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Ludwig Lettau Private Practice
🇺🇸Charleston, South Carolina, United States