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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002240

Enrollment

Unknown

Registered

2001-08-31

Start date

1999-03-31

Completion date

2001-12-31

Last updated

2011-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Didanosine, Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir

Brief 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.

Detailed 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.

Interventions

DRUGAtazanavir

DRUGNelfinavir mesylate

DRUGStavudine

DRUGDidanosine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026