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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Atazanavir; Drug: Didanosine; Drug: Nelfinavir mesylate; Drug: Stavudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002240

AI424-007

302A

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.