Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00004584
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.

Detailed Description

This is a three-arm study; patients are randomized to receive BMS-232632 at two different doses or RTV in combination with SQV and two nucleoside analogues over 48 weeks. Randomization is stratified for baseline phenotypic sensitivity.

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2000-02-10
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Primary Completion: 2002-01
• Study Completion: 2002-01
• 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 (38)

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

AIDS Healthcare Foundation; 🇺🇸 Los Angeles, California, United States

Robert Scott MD; 🇺🇸 Oakland, California, United States

Univ of California - Davis Med Ctr / CARES; 🇺🇸 Sacramento, California, United States

Avalar Medical Group; 🇺🇸 Tarzana, California, United States

Yale Univ School of Medicine / AIDS Program; 🇺🇸 New Haven, Connecticut, United States

Community Research Initiative of South Florida; 🇺🇸 Coral Gables, Florida, United States

HIV Clinical Research; 🇺🇸 Fort Lauderdale, Florida, United States

Infectious Disease Research Institute; 🇺🇸 Tampa, Florida, United States

Infectious Disease Specialists of Atlanta; 🇺🇸 Decatur, Georgia, United States

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