A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor

Stopped early · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.

Key facts

Study ID

NCT00028067

Run by

Bristol-Myers Squibb

People needed

500

Starts

2001-08-01

Expected to finish

2002-04-01

Last updated by the study team

2011-05-04

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• 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.

You may not qualify if…

• Patients may not be eligible for this study if they:
• 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.

Where it is running

• 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
• Health for Life Clinic — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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