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

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002240
• Lead Sponsor: Bristol-Myers Squibb

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 Timeline

• Study Start: 1999-03
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Primary Completion: 2001-12
• Study Completion: 2001-12
• Status Verified: 2011-04
• Disposition First Submitted: 2011-04-13
• Disposition First Submitted QC: 2011-04-13
• Disposition First Posted: 2011-04-25
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (17)

Clinsites / Sorra Research Ctr; 🇺🇸 Birmingham, Alabama, United States

Univ of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

UCSD Treatment Ctr; 🇺🇸 San Diego, California, United States

UCSF - San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Univ of Colorado / Health Science Ctr; 🇺🇸 Denver, Colorado, United States

ViRx / Dupont Circle Physicians Group; 🇺🇸 Washington, District of Columbia, United States

AIDS Research Consortium of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Rush Presbyterian - Saint Luke's Med Ctr; 🇺🇸 Chicago, Illinois, United States

Washington Univ School of Medicine; 🇺🇸 St Louis, Missouri, United States

Albany Med College; 🇺🇸 Albany, New York, United States

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