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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Atazanavir (Drug); Lamivudine/Zidovudine (Drug); Efavirenz (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb


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).

Clinical Details

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

Study design: Masking: Double-Blind, Primary Purpose: 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.


Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

AKH Wien, Wien, Austria

Pulmologisches Zentrum Der Stadt Wien, Wien, Austria

CHU Saint Pierre, Brussels, Belgium

UZ Gasthuisberg, Leuven, Belgium

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, Santiago, Chile

SEMECO, San Jose, Costa Rica

Hopital Hotel Dieu de Lyon, Lyon, France

Services des Maladies Infectieuses, Paris Cedex 12, France

CHU De Bicetre, Paris, France

Hopital Cochin - Port Royal, Paris, France

Hospital Gustave Dron, Tourcoing, France

Rheinische Friedrich Wilhelms Universitaet Medizinische, Bonn, Germany

Univ Zu Koeln, Koeln, Germany

Hosp General San Juan de Dios, Guatemala, Guatemala

Hosp Roosevelt Chief Infectious Diseases Unit, Guatemala, Guatemala

Saint Laszlo Hosp, Budapest, Hungary

Kaplan Med Ctr, Rehovot, Israel

Ospedale S Orsola, Bologna, Italy

Immunoligia Universita Cagliari, Cagliari, Italy

Ospedale Luigi Sacco Cargnel, Milano, Italy

Ospedale S Raffaele, Milano, Italy

Ospedale degli Infermi, Rimini, Italy

Cat All Immun Clin, Roma, Italy

Ospedale Amedeo de Savoia, Torino, Italy

Ospedale Amedeo di Savoia, Torino, Italy

Hosp Kuala Lumpur, Kuala Lumpur, Malaysia

Univ of Malaya Med Ctr, Kuala Lumpur, Malaysia

Consultorio Royal Ctr, Panama, Panama

Hosp Edgardo Rebagliati, Lima, Peru

Hosp Guillermo Almenara-Medicina 1, Lima, Peru

Hosp Nacional Arzobispo Loayza-PROCETS, Lima, Peru

Hosp Nacional Cayetano Heredia, Lima, Peru

Hosp Nacional dos de Mayo, Lima, Peru

Hosp De Santa Maria, Lisboa, Portugal

Hosp De Sao Joao, Porto, Portugal

Clinical Research Puerto Rico Inc, San Juan 009091711, Puerto Rico

San Juan VAMC, San Juan 009265800, Puerto Rico

Federal AIDS Ctr, Moscow, Russian Federation

Infectious Hosp 30, St Petersburg, Russian Federation

Ust Izhora Fed Infectious Hosp, St Petersburg, Russian Federation

Brooklyn Med Ctr, Cape Town, South Africa

Tygerberg Hosp, Cape Town, South Africa

Chris Hani Baragwanath Hosp, Johannesburg, South Africa

Toga Lab, Johannesburg, South Africa

Hosp Clinic, Barcelona, Spain

Hosp Germans Trias I Pujol, Barcelona, Spain

Hosp de Basurto / Enfermedades Infecciosas, Bilboa, Spain

Hosp Reina Sofia, Cordoba, Spain

Hosp Carlos III, Madrid, Spain

Hosp Ramon y Cajal, Madris, Spain

Hosp Nuestra Senora de Covadonga, Oviedo, Spain

Hosp Virgen Del Rocio, Sevilla, Spain

Universitatsspital Zurich, Zurich, Switzerland

Rajavithi Hosp, Bangkok, Thailand

Ramathibodi Hosp, Bangkok, Thailand

Siriraj Hosp / Mahidol Univ, Bangkok, Thailand

Vajira Hosp, Bangkok, Thailand

Chiangmai Univ, Chiang Mai, Thailand

King's College Hosp, Cambewell, United Kingdom

Saint James Hosp, Dublin, United Kingdom

Royal Free Hosp, London, United Kingdom

Hosp U de Caracas / Ciudad, Caracas, Venezuela

Hosp Vargas de Caracas, Caracas, Venezuela

Hosp Dr Domingo Luciani, Miranda, Venezuela

Univ of Alberta/Division of Inf Dis/Dept of Med, Edmonton, Alberta, Canada

Phoenix Body Positive, Phoenix, Arizona 85006, United States

Univ of British Columbia, Vancouver, British Columbia, Canada

Univ of Southern California, Los Angeles, California 90033, United States

Saint Francis Mem Hosp / HIV Care Unit, San Francisco, California 94109, United States

Dr Bruce Rashbaum, Washington, District of Columbia 20037, United States

Dupont Circle Physicians Group, Washington, District of Columbia 200091104, United States

North Broward Hosp District / HIV Clinical Research, Fort Lauderdale, Florida 33311, United States

Associates in Research, Fort Myers, Florida 33901, United States

Steinhart Medical Associates, Miami, Florida 33133, United States

Saint Josephs Comprehensive Research Institute, Tampa, Florida 33607, United States

Emory Univ, Atlanta, Georgia 30308, United States

The CORE Ctr, Chicago, Illinois 60612, United States

Univ of Kansas School of Medicine, Wichita, Kansas 672143124, United States

Univ of Michigan Hospitals and Health Ctrs, Ann Arbor, Michigan 481090378, United States

Washington Univ School of Medicine, St Louis, Missouri 63108, United States

Univ of Nebraska Medical Ctr, Omaha, Nebraska 681985400, United States

Robert Wood Johnson Med School/UMDNJ, New Brunswick, New Jersey 089030019, United States

UMDNJ - New Jersey Med School, Newark, New Jersey 071032757, United States

ID Care Inc, Somerville, New Jersey 08876, United States

Univ of NM, Albuquerque, New Mexico 87131, United States

Duke Univ Med Ctr / Infectious Disease Clinic, Durham, North Carolina 27710, United States

Jemsek Clinic, Huntersville, North Carolina 28078, United States

Ohio State Univ Hosp, Columbus, Ohio 432101282, United States

McMaster Univ Med Ctr, Hamilton, Ontario, Canada

Gary Rubin, Toronto, Ontario, Canada

Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States

Julio Arroyo, West Columbia, South Carolina 29169, United States

Methodist Healthcare, Memphis, Tennessee 38104, United States

Oaklawn Physicians Group, Dallas, Texas 75219, United States

Tarrant County Infectious Diseases Associates, Fort Worth, Texas 76104, United States

Montrose Clinic, Houston, Texas 77006, United States

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: February 2001
Last updated: April 28, 2011

Page last updated: August 23, 2015

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