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

Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Ritonavir; Drug: Saquinavir; Drug: Atazanavir

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Ottawa General Hospital
    • Toronto, Ontario, Canada
      • Toronto Hosp
  • Quebec
    • Montreal, Quebec, Canada
      • Montreal Chest Institute
• France
  • Bordeaux, France
    • Hopital Pellegrin Tripode
  • Nantes, France
    • Hôpital de l'Hôtel Dieu
  • Nice, France
    • Hôpital de l'Archet 1
  • Paris Cedex 13, France
    • Srev Du Pr Gentilini
  • Pessac, France
    • Hopital De Haut Leveque
  • Tourcoing, France
    • Hospital Gustave Dron
  • Villejuif, France
    • Hôpital Paul Brousse
• Germany
  • Hamburg, Germany
    • Brennerstr 71
  • Hanover, Germany
    • Georg-Str 46
  • Munich, Germany
    • Praxisgemeinschaft
• Italy
  • Antella, Italy
    • Reparto Malattie Infettive
  • Milano, Italy
    • Clinical Malattie Infettive
  • Milano, Italy
    • Ospedale Luigi Cacco Moroni
  • Modena, Italy
    • Clinical Malattie Infettive / Univ Modena
  • Rimini, Italy
    • Ospedale Degli Infermi
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35203
      • Sorra Research Ctr / Med Forum
  • California
    • Los Angeles, California, United States, 90027
      • AIDS Healthcare Foundation
    • Oakland, California, United States, 94609
      • Robert Scott MD
    • Sacramento, California, United States, 95817
      • Univ of California - Davis Med Ctr / CARES
    • Tarzana, California, United States, 91356
      • Avalar Medical Group
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Univ School of Medicine / AIDS Program
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Community Research Initiative of South Florida
    • Fort Lauderdale, Florida, United States, 33316
      • HIV Clinical Research
    • Tampa, Florida, United States, 33614
      • Infectious Disease Research Institute
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Infectious Disease Specialists of Atlanta
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State Univ Med Ctr / HIV Outpatient Clinic
  • New York
    • Albany, New York, United States, 12208
      • Albany Med College
    • New York, New York, United States, 10011
      • St Vincents Hosp / Clinical Research Program
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Univ Hosps of Cleveland
  • Oregon
    • Portland, Oregon, United States, 97210
      • The Research and Education Group
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Julio Arroyo
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt Univ Med Ctr
  • Texas
    • Dallas, Texas, United States, 75235
      • Univ of Texas Southwestern Med Ctr of Dallas
    • El Paso, Texas, United States, 79905
      • Texas Tech Health Sciences Ctr
    • Houston, Texas, United States, 77006
      • Houston Clinical Research Network / Div of Montrose Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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)
• 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)

Study record dates

Study Major Dates

• Study Start: December 1, 1999
• Primary Completion (Actual): January 1, 2002
• Study Completion (Actual): January 1, 2002

Study Registration Dates

• First Submitted: February 10, 2000
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): May 4, 2011
• Last Update Submitted That Met QC Criteria: April 28, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; HIV Protease Inhibitors; Ritonavir; Dose-Response Relationship, Drug; Saquinavir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Atazanavir Sulfate; Saquinavir
• Other Study ID Numbers: 302B; AI424-009