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

Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen

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.

Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.

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.