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

NCT ID: NCT00004584

Last Updated: 2011-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2002-01-31

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Atazanavir

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Saquinavir

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.
• Have a viral load (level of HIV in the blood) of at least 2,000 copies/ml.
• Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness).
• Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load.
• Will most likely respond well to the study drugs, as shown by the results of a lab test.
• Are at least 18 years old.
• Agree to use effective barrier methods of birth control (such as condoms).
• Are available for follow-up for at least 48 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment.
• Have only recently become HIV positive.
• Abuse alcohol or drugs.
• Have severe diarrhea within 30 days of study entry.
• Have hemophilia.
• Have a history of pancreatitis.
• Have hepatitis within 30 days of study entry.
• Have peripheral neuropathy (a painful condition affecting the nervous system).
• Are unable to take medications by mouth.
• Are pregnant or breast-feeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Locations

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

Louisiana State Univ Med Ctr / HIV Outpatient Clinic

New Orleans, Louisiana, United States

Albany Med College

Albany, New York, United States

St Vincents Hosp / Clinical Research Program

New York, New York, United States

Univ Hosps of Cleveland

Cleveland, Ohio, United States

The Research and Education Group

Portland, Oregon, United States

Julio Arroyo

West Columbia, South Carolina, United States

Vanderbilt Univ Med Ctr

Nashville, Tennessee, United States

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Texas Tech Health Sciences Ctr

El Paso, Texas, United States

Houston Clinical Research Network / Div of Montrose Clinic

Houston, Texas, United States

Ottawa General Hospital

Ottawa, Ontario, Canada

Toronto Hosp

Toronto, Ontario, Canada

Montreal Chest Institute

Montreal, Quebec, Canada

Hopital Pellegrin Tripode

Bordeaux, , France

Hopital De L'Hotel Dieu

Nantes, , France

Hopital De L'Archet 1

Nice, , France

Srev Du Pr Gentilini

Paris, , France

Hopital De Haut Leveque

Pessac, , France

Hospital Gustave Dron

Tourcoing, , France

Hopital Paul Brousse

Villejuif, , France

Brennerstr 71

Hamburg, , Germany

Georg-Str 46

Hanover, , Germany

Praxisgemeinschaft

Munich, , Germany

Reparto Malattie Infettive

Antella, , Italy

Clinical Malattie Infettive

Milan, , Italy

Ospedale Luigi Cacco Moroni

Milan, , Italy

Clinical Malattie Infettive / Univ Modena

Modena, , Italy

Ospedale degli Infermi

Rimini, , Italy

Countries

United States; Canada; France; Germany; Italy

References

Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424009: Atazanavir plus Saquinavir once daily favorably affects total cholesterol (TC), fasting triglyceride (TG), and fasting LDL cholesterol (LDL) profiles in patients failing prior therapy week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24-28 (abstract no 42)

Reference Type: BACKGROUND

Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424-009: Once-Daily Atazanavir plus Saquinavir favorably affects total cholesterol and fasting triglycerides in patients failing prior PI therapy study BMS-009,week 24. 41st Annual Conf on Antimicrobial Agents and Chemotherapy. 2001 Feb 16-19 (abstract no LB-16)

Reference Type: BACKGROUND

Other Identifiers

AI424-009

Identifier Type: -

Identifier Source: secondary_id

302B

Identifier Type: -

Identifier Source: org_study_id