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

Bristol-Myers Squibb

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

HIV Infections

Interventions

AtazanavirDRUG

Nelfinavir mesylateDRUG

StavudineDRUG

DidanosineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

Clinsites / Sorra Research Ctr

Birmingham, Alabama, United States

Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.