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

Bristol-Myers Squibb31 sites in 2 countriesStarted: March 1999Last updated: May 4, 2011

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor
Locations: 31

Study Overview Study Design Eligibility Criteria Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Primary Purpose: Treatment

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Investigators

Sponsor

Bristol-Myers Squibb

Sponsor Class

Industry

Study Sites (31)

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