A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor
NCT ID: NCT00028067
Last Updated: 2011-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
500 participants
INTERVENTIONAL
2001-08-31
2002-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Atazanavir
Nelfinavir mesylate
Eligibility Criteria
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Inclusion Criteria
* Have a viral load of 1000 or more copies/ml within 3 weeks before randomization. Have a CD4 cell count of 50 or more cells/mm3 within 3 weeks prior to randomization.
* Are at least 16 years old (or the minimum age by local requirements).
* Have had more than 16 weeks of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and/or nucleoside reverse transcriptase inhibitor (NRTI).
* Use effective barrier method of contraception.
* Give written informed consent.
* Are available for follow-up for at least 52 weeks.
Exclusion Criteria
* Have used a protease inhibitor (PI) treatment for more than 7 days or within 30 days prior to screening.
* Have a newly-diagnosed HIV-related infection or any medical condition requiring relatively short but intense therapy at the time of enrollment.
* Have hepatitis in the 30 days before the study. Patients with long-term hepatitis are eligible if their liver function meets certain requirements.
* Are unable to demonstrate responsiveness to a provided NRTI.
* Have had previous or expect a need for therapy with agents that may cause damage to nerve tissue, the pancreas, the liver, bone marrow, or cells within 3 months of study start.
* Use too much alcohol or drugs to be able to follow the study therapy; or if they use enough to increase the risk of developing pancreatitis or chemical hepatitis.
* Have severe diarrhea within 30 days prior to study entry.
* Are pregnant or breast-feeding.
* Have a history of hemophilia.
* Have history or signs of bilateral peripheral neuropathy.
* Have cardiomyopathy.
* Have certain heart problems.
* Cannot tolerate oral medication.
* Have any other problems that would interfere with the study.
16 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Principal Investigators
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Michael Giordano
Role: STUDY_DIRECTOR
Locations
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Health for Life Clinic
Little Rock, Arkansas, United States
East Bay AIDS Ctr
Berkeley, California, United States
Orange County Ctr for Special Immunology
Fountain Valley, California, United States
Tower Infectious Diseases
Los Angeles, California, United States
Kaiser Hospital
Sacramento, California, United States
HIV Institute / Davies Med Ctr
San Francisco, California, United States
Kaiser Foundation Hospital
San Francisco, California, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Larry Bush
Atlantis, Florida, United States
Bach and Godofsky
Bradenton, Florida, United States
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, United States
Gary Richmond MD
Fort Lauderdale, Florida, United States
Infectious Diseases Associates
Sarasota, Florida, United States
Daniel Seekins
Tampa, Florida, United States
Infectious Disease Research Inst
Tampa, Florida, United States
Philip Brachman
Atlanta, Georgia, United States
Med College of Georgia
Augusta, Georgia, United States
Cook County Gen Hosp / Division of Infect Diseases
Chicago, Illinois, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Community Research Initiative of New England
Brookline, Massachusetts, United States
CRI - Springfield
Springfield, Massachusetts, United States
Henry Ford Hosp
Detroit, Michigan, United States
Infectious Disease Clinic
Warren, Michigan, United States
Washington Univ School of Medicine
St Louis, Missouri, United States
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, United States
Community Research Initiative on AIDS
New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Carolinas Med Ctr
Charlotte, North Carolina, United States
Piedmont Infectious Disease Consultants
Hickory, North Carolina, United States
Jemsek Clinic
Huntersville, North Carolina, United States
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, United States
Summa Health System
Akron, Ohio, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, United States
Research & Education Group
Portland, Oregon, United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States
Ludwig Lettau Private Practice
Charleston, South Carolina, United States
Univ of South Carolina School of Medicine
Columbia, South Carolina, United States
North Texas Center for AIDS & Clinical Research
Dallas, Texas, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States
Joseph Gathe
Houston, Texas, United States
Univ TX Health Science Ctr
Houston, Texas, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, United States
Downtown Infectious Diseases Clinic
Vancouver, British Columbia, Canada
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Hospital General De Mexico
Mexico City, , Mexico
Hospital Regional
Mexico City, , Mexico
Instituto Nacional de Enfermedades Respiratorias
Mexico City, , Mexico
Instituto Nacional de la Nutricion
Mexico City, , Mexico
Ponce School of Medicine
Ponce, , Puerto Rico
Hepatology / Infectious Diseases
Santruce, , Puerto Rico
Program on AIDS / Thai Red Cross Society
Bangkok, , Thailand
Ramathibodi Hosp
Bangkok, , Thailand
Siriraj Hosp / Mahidol Univ
Bangkok, , Thailand
Khonkaen Univ
Khonkaen, , Thailand
Countries
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Other Identifiers
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AI424-037
Identifier Type: -
Identifier Source: secondary_id
302F
Identifier Type: -
Identifier Source: org_study_id
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