Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have an HIV blood level between 2,000 and 200,000 copies/ml.

• Have a CD4 cell count of at least 100 cells/mm3.

• Are 18 years of age or older.

• Are available for follow-up for at least 48 weeks.

• Agree to use a barrier method of birth control (such as condoms) during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have ever received anti-HIV (antiretroviral) treatment.

• Have an HIV-related opportunistic infection or condition at the time of study entry.

• Have primary HIV infection, meaning they have recently been infected.

• Have had severe diarrhea within the 30 days before study entry.

• Have hemophilia.

• Have a history of pancreatitis, hepatitis, or a peripheral neuropathy.

• Are unable to tolerate oral medication.

• Are pregnant or breast-feeding.

• Abuse alcohol or drugs.