A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine

April 28, 2011 updated by: Bristol-Myers Squibb

A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine

The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multinational, 2-arm study. Patients in 1 arm receive BMS-232632 plus EFV placebo capsules. Patients in the other arm receive EFV plus BMS-232632 placebo. Both arms also receive a fixed dose of ZDV-3TC.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • AKH Wien
      • Wien, Austria
        • Pulmologisches Zentrum Der Stadt Wien
  • Belgium
      • Brussels, Belgium
        • CHU Saint Pierre
      • Leuven, Belgium
        • UZ Gasthuisberg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Univ of Alberta/Division of Inf Dis/Dept of Med
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Univ of British Columbia
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster Univ Med Ctr
      • Toronto, Ontario, Canada
        • Gary Rubin
  • Chile
      • Santiago, Chile
        • Fundacion Arriaran
      • Santiago, Chile
        • Hosp Clinico de La Pontificia Universidad Catolica de Chile
      • Santiago, Chile
        • Hosp Sotero de Rio
      • Santiago, Chile
        • Servicio de Dermatologia-Hosp del Salvador
  • Costa Rica
      • San Jose, Costa Rica
        • SEMECO
  • France
      • Lyon, France
        • Hopital Hotel Dieu de Lyon
      • Paris, France
        • CHU de Bicêtre
      • Paris, France
        • Hopital Cochin - Port Royal
      • Paris Cedex 12, France
        • Services des Maladies Infectieuses
      • Tourcoing, France
        • Hospital Gustave Dron
  • Germany
      • Bonn, Germany
        • Rheinische Friedrich Wilhelms Universitaet Medizinische
      • Koeln, Germany
        • Univ Zu Koeln
  • Guatemala
      • Guatemala, Guatemala
        • Hosp Roosevelt Chief Infectious Diseases Unit
      • Guatemala, Guatemala
        • Hosp General San Juan de Dios
  • Hungary
      • Budapest, Hungary
        • Saint Laszlo Hosp
  • Israel
      • Rehovot, Israel
        • Kaplan Med Ctr
  • Italy
      • Bologna, Italy
        • Ospedale S Orsola
      • Cagliari, Italy
        • Immunoligia Universita Cagliari
      • Milano, Italy
        • Ospedale Luigi Sacco Cargnel
      • Milano, Italy
        • Ospedale S Raffaele
      • Rimini, Italy
        • Ospedale degli Infermi
      • Roma, Italy
        • Cat All Immun Clin
      • Torino, Italy
        • Ospedale Amedeo di Savoia
      • Torino, Italy
        • Ospedale Amedeo de Savoia
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Hosp Kuala Lumpur
      • Kuala Lumpur, Malaysia
        • Univ of Malaya Med Ctr
  • Panama
      • Panama, Panama
        • Consultorio Royal Ctr
  • Peru
      • Lima, Peru
        • Hosp Nacional dos de Mayo
      • Lima, Peru
        • Hosp Edgardo Rebagliati
      • Lima, Peru
        • Hosp Guillermo Almenara-Medicina 1
      • Lima, Peru
        • Hosp Nacional Arzobispo Loayza-PROCETS
      • Lima, Peru
        • Hosp Nacional Cayetano Heredia
  • Portugal
      • Lisboa, Portugal
        • Hosp De Santa Maria
      • Porto, Portugal
        • Hosp De Sao Joao
  • Puerto Rico
      • San Juan, Puerto Rico, 009091711
        • Clinical Research Puerto Rico Inc
      • San Juan, Puerto Rico, 009265800
        • San Juan Vamc
  • Russian Federation
      • Moscow, Russian Federation
        • Federal AIDS Ctr
      • St Petersburg, Russian Federation
        • Infectious Hosp 30
      • St Petersburg, Russian Federation
        • Ust Izhora Fed Infectious Hosp
  • South Africa
      • Cape Town, South Africa
        • Tygerberg Hosp
      • Cape Town, South Africa
        • Brooklyn Med Ctr
      • Johannesburg, South Africa
        • Chris Hani Baragwanath Hosp
      • Johannesburg, South Africa
        • Toga Lab
  • Spain
      • Barcelona, Spain
        • Hosp Clinic
      • Barcelona, Spain
        • Hosp Germans Trias I Pujol
      • Bilboa, Spain
        • Hosp de Basurto / Enfermedades Infecciosas
      • Cordoba, Spain
        • Hosp Reina Sofia
      • Madrid, Spain
        • Hosp Carlos III
      • Madris, Spain
        • Hosp Ramon y Cajal
      • Oviedo, Spain
        • Hosp Nuestra Senora de Covadonga
      • Sevilla, Spain
        • Hosp Virgen Del Rocio
  • Switzerland
      • Zurich, Switzerland
        • Universitatsspital Zurich
  • Thailand
      • Bangkok, Thailand
        • Ramathibodi Hosp
      • Bangkok, Thailand
        • Siriraj Hosp / Mahidol Univ
      • Bangkok, Thailand
        • Rajavithi Hosp
      • Bangkok, Thailand
        • Vajira Hosp
      • Chiang Mai, Thailand
        • Chiangmai Univ
  • United Kingdom
      • Cambewell, United Kingdom
        • King's College Hosp
      • Dublin, United Kingdom
        • Saint James Hosp
      • London, United Kingdom
        • Royal Free Hosp
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Body Positive
    • California
      • Los Angeles, California, United States, 90033
        • Univ of Southern California
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp / HIV Care Unit
    • District of Columbia
      • Washington, District of Columbia, United States, 200091104
        • Dupont Circle Physicians Group
      • Washington, District of Columbia, United States, 20037
        • Dr Bruce Rashbaum
    • Florida
      • Fort Lauderdale, Florida, United States, 33311
        • North Broward Hosp District / HIV Clinical Research
      • Fort Myers, Florida, United States, 33901
        • Associates in Research
      • Miami, Florida, United States, 33133
        • Steinhart Medical Associates
      • Tampa, Florida, United States, 33607
        • Saint Josephs Comprehensive Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Univ
    • Illinois
      • Chicago, Illinois, United States, 60612
        • The CORE Ctr
    • Kansas
      • Wichita, Kansas, United States, 672143124
        • Univ of Kansas School of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 481090378
        • Univ of Michigan Hospitals and Health Ctrs
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Washington Univ School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 681985400
        • Univ of Nebraska Medical CTR
    • New Jersey
      • New Brunswick, New Jersey, United States, 089030019
        • Robert Wood Johnson Med School/UMDNJ
      • Newark, New Jersey, United States, 071032757
        • UMDNJ - New Jersey Med School
      • Somerville, New Jersey, United States, 08876
        • ID Care Inc
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Univ of NM
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr / Infectious Disease Clinic
      • Huntersville, North Carolina, United States, 28078
        • Jemsek Clinic
    • Ohio
      • Columbus, Ohio, United States, 432101282
        • Ohio State Univ Hosp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Julio Arroyo
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist Healthcare
    • Texas
      • Dallas, Texas, United States, 75219
        • Oaklawn Physicians Group
      • Fort Worth, Texas, United States, 76104
        • Tarrant County Infectious Diseases Associates
      • Houston, Texas, United States, 77006
        • Montrose Clinic
  • Venezuela
      • Caracas, Venezuela
        • Hosp U de Caracas / Ciudad
      • Caracas, Venezuela
        • Hosp Vargas de Caracas
      • Miranda, Venezuela
        • Hosp Dr Domingo Luciani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Have a viral load of 2,000 or more copies/ml and a CD4 cell count of 100 or more cells/mm3 (or 75 or more cells/mm3 with no prior history of AIDS-defining diagnosis) within 2 weeks before randomization.
  • Are at least 16 years old.
  • Have signed consent of parent or guardian if under 18 years of age.
  • Are willing to use effective barrier methods of birth control.
  • Are available for follow-up for at least 52 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have had anti-HIV treatment within 30 days before screening.
  • Have a recently diagnosed HIV-related infection.
  • Have any medical condition requiring treatment at enrollment.
  • Have recently become HIV infected.
  • Have acute hepatitis within 30 days of study entry. Certain patients with chronic hepatitis will be eligible.
  • Expect to need or have taken drugs with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months before study. Expect to need methadone, ribavirin/interferons, neurotoxic drugs or drugs that affect CYP3A4.
  • Abuse alcohol or drugs.
  • Have severe diarrhea within 30 days before study entry.
  • Are pregnant or breast-feeding.
  • Have a history of hemophilia.
  • Have a history of bilateral peripheral neuropathy.
  • Cannot take medicines by mouth.
  • Have any other conditions that the doctor thinks would interfere with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

April 1, 2003

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

March 31, 2001

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 302C
  • AI424-034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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