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

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.