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

• Status: Terminated
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; HIV Protease Inhibitors; Nelfinavir; Protease Inhibitors

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.