Clinical Trial: A Comparison of BMS-232632 with Efavirenz, Each in Combination with Zidovudine-Lamivudine

This study is no longer recruiting patients.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb

Purpose

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).

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Atazanavir
 Drug: Lamivudine/Zidovudine
 Drug: Efavirenz
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Double-Blind

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

Further Study Details: 

Study start: February 2001

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.

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Location Information


Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85006,  United States

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

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

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

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

Florida
      Steinhart Medical Associates, Miami,  Florida,  33133,  United States

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

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

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

Georgia
      Emory Univ, Atlanta,  Georgia,  30308,  United States

Illinois
      The CORE Ctr, Chicago,  Illinois,  60612,  United States

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

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

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

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

New Jersey
      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

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

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

      Jemsek Clinic, Huntersville,  North Carolina,  28078,  United States

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

Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States

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

Tennessee
      Methodist Healthcare, Memphis,  Tennessee,  38104,  United States

Texas
      Oaklawn Physicians Group, Dallas,  Texas,  75219,  United States

      Montrose Clinic, Houston,  Texas,  77006,  United States

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

Austria
      Pulmologisches Zentrum Der Stadt Wien, Wien,  Austria

      AKH Wien, Wien,  Austria

Belgium
      CHU Saint Pierre, Brussels,  Belgium

      UZ Gasthuisberg, Leuven,  Belgium

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

Canada, British Columbia
      Univ of British Columbia, Vancouver,  British Columbia,  Canada

Canada, Ontario
      McMaster Univ Med Ctr, Hamilton,  Ontario,  Canada

      Gary Rubin, Toronto,  Ontario,  Canada

Chile
      Fundacion Arriaran, Santiago,  Chile

      Hosp Sotero de Rio, Santiago,  Chile

      Servicio de Dermatologia-Hosp del Salvador, Santiago,  Chile

      Hosp Clinico de La Pontificia Universidad Catolica de Chile, Santiago,  Chile

Costa Rica
      SEMECO, San Jose,  Costa Rica

France
      Services des Maladies Infectieuses, Paris Cedex 12,  France

      Hopital Cochin - Port Royal, Paris,  France

      Hopital Hotel Dieu de Lyon, Lyon,  France

      CHU De Bicetre, Paris,  France

      Hospital Gustave Dron, Tourcoing,  France

Germany
      Rheinische Friedrich Wilhelms Universitaet Medizinische, Bonn,  Germany

      Univ Zu Koeln, Koeln,  Germany

Guatemala
      Hosp Roosevelt Chief Infectious Diseases Unit, Guatemala,  Guatemala

      Hosp General San Juan de Dios, Guatemala,  Guatemala

Hungary
      Saint Laszlo Hosp, Budapest,  Hungary

Israel
      Kaplan Med Ctr, Rehovot,  Israel

Italy
      Ospedale S Raffaele, Milano,  Italy

      Ospedale S Orsola, Bologna,  Italy

      Ospedale Luigi Sacco Cargnel, Milano,  Italy

      Ospedale degli Infermi, Rimini,  Italy

      Ospedale Amedeo de Savoia, Torino,  Italy

      Ospedale Amedeo di Savoia, Torino,  Italy

      Cat All Immun Clin, Roma,  Italy

      Immunoligia Universita Cagliari, Cagliari,  Italy

Malaysia
      Univ of Malaya Med Ctr, Kuala Lumpur,  Malaysia

      Hosp Kuala Lumpur, Kuala Lumpur,  Malaysia

Panama
      Consultorio Royal Ctr, Panama,  Panama

Peru
      Hosp Nacional dos de Mayo, Lima,  Peru

      Hosp Nacional Cayetano Heredia, Lima,  Peru

      Hosp Nacional Arzobispo Loayza-PROCETS, Lima,  Peru

      Hosp Guillermo Almenara-Medicina 1, Lima,  Peru

      Hosp Edgardo Rebagliati, Lima,  Peru

Portugal
      Hosp De Santa Maria, Lisboa,  Portugal

      Hosp De Sao Joao, Porto,  Portugal

Puerto Rico
      San Juan VAMC, San Juan,  009265800,  Puerto Rico

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

Russian Federation
      Federal AIDS Ctr, Moscow,  Russian Federation

      Infectious Hosp 30, St Petersburg,  Russian Federation

      Ust Izhora Fed Infectious Hosp, St Petersburg,  Russian Federation

South Africa
      Tygerberg Hosp, Cape Town,  South Africa

      Chris Hani Baragwanath Hosp, Johannesburg,  South Africa

      Brooklyn Med Ctr, Cape Town,  South Africa

      Toga Lab, Johannesburg,  South Africa

Spain
      Hosp Clinic, Barcelona,  Spain

      Hosp Germans Trias I Pujol, Barcelona,  Spain

      Hosp Carlos III, Madrid,  Spain

      Hosp Virgen Del Rocio, Sevilla,  Spain

      Hosp Ramon y Cajal, Madris,  Spain

      Hosp de Basurto / Enfermedades Infecciosas, Bilboa,  Spain

      Hosp Reina Sofia, Cordoba,  Spain

      Hosp Nuestra Senora de Covadonga, Oviedo,  Spain

Switzerland
      Universitatsspital Zurich, Zurich,  Switzerland

Thailand
      Siriraj Hosp / Mahidol Univ, Bangkok,  Thailand

      Chiangmai Univ, Chiang Mai,  Thailand

      Vajira Hosp, Bangkok,  Thailand

      Rajavithi Hosp, Bangkok,  Thailand

      Ramathibodi Hosp, Bangkok,  Thailand

United Kingdom
      Royal Free Hosp, London,  United Kingdom

      King's College Hosp, Cambewell,  United Kingdom

      Saint James Hosp, Dublin,  United Kingdom

Venezuela
      Hosp Dr Domingo Luciani, Miranda,  Venezuela

      Hosp U de Caracas / Ciudad, Caracas,  Venezuela

      Hosp Vargas de Caracas, Caracas,  Venezuela

More Information

Study ID Numbers:  302C; AI424-034
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  March 31, 2001
ClinicalTrials.gov Identifier:  NCT00013897
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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