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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00013897
First received: March 31, 2001
Last updated: April 28, 2011
Last verified: April 2011
  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 Intervention Phase
HIV Infections
Drug: Atazanavir
Drug: Lamivudine/Zidovudine
Drug: Efavirenz
Phase 3

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: February 2001
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013897

  Hide Study Locations
Locations
United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85006
United States, California
Univ of Southern California
Los Angeles, California, United States, 90033
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, United States, 94109
United States, District of Columbia
Dr Bruce Rashbaum
Washington, District of Columbia, United States, 20037
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 200091104
United States, Florida
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, United States, 33311
Associates in Research
Fort Myers, Florida, United States, 33901
Steinhart Medical Associates
Miami, Florida, United States, 33133
Saint Josephs Comprehensive Research Institute
Tampa, Florida, United States, 33607
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
United States, Illinois
The CORE Ctr
Chicago, Illinois, United States, 60612
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 672143124
United States, Michigan
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, United States, 481090378
United States, Missouri
Washington Univ School of Medicine
St Louis, Missouri, United States, 63108
United States, Nebraska
Univ of Nebraska Medical Ctr
Omaha, Nebraska, United States, 681985400
United States, New Jersey
Robert Wood Johnson Med School/UMDNJ
New Brunswick, New Jersey, United States, 089030019
UMDNJ - New Jersey Med School
Newark, New Jersey, United States, 071032757
ID Care Inc
Somerville, New Jersey, United States, 08876
United States, New Mexico
Univ of NM
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Duke Univ Med Ctr / Infectious Disease Clinic
Durham, North Carolina, United States, 27710
Jemsek Clinic
Huntersville, North Carolina, United States, 28078
United States, Ohio
Ohio State Univ Hosp
Columbus, Ohio, United States, 432101282
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Methodist Healthcare
Memphis, Tennessee, United States, 38104
United States, Texas
Oaklawn Physicians Group
Dallas, Texas, United States, 75219
Tarrant County Infectious Diseases Associates
Fort Worth, Texas, United States, 76104
Montrose Clinic
Houston, Texas, United States, 77006
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
Servicio de Dermatologia-Hosp del Salvador
Santiago, Chile
Hosp Sotero de Rio
Santiago, Chile
Hosp Clinico de La Pontificia Universidad Catolica de Chile
Santiago, Chile
Costa Rica
SEMECO
San Jose, Costa Rica
France
Hopital Hotel Dieu de Lyon
Lyon, France
Hopital Cochin - Port Royal
Paris, France
CHU De Bicetre
Paris, France
Services des Maladies Infectieuses
Paris Cedex 12, 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 Orsola
Bologna, Italy
Immunoligia Universita Cagliari
Cagliari, Italy
Ospedale S Raffaele
Milano, Italy
Ospedale Luigi Sacco Cargnel
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
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 Guillermo Almenara-Medicina 1
Lima, Peru
Hosp Nacional Cayetano Heredia
Lima, Peru
Hosp Nacional Arzobispo Loayza-PROCETS
Lima, Peru
Hosp Edgardo Rebagliati
Lima, Peru
Portugal
Hosp De Santa Maria
Lisboa, Portugal
Hosp De Sao Joao
Porto, Portugal
Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 009091711
San Juan VAMC
San Juan, Puerto Rico, 009265800
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
Brooklyn Med Ctr
Cape Town, South Africa
Toga Lab
Johannesburg, South Africa
Chris Hani Baragwanath Hosp
Johannesburg, South Africa
Spain
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
Switzerland
Universitatsspital Zurich
Zurich, Switzerland
Thailand
Ramathibodi Hosp
Bangkok, Thailand
Rajavithi Hosp
Bangkok, Thailand
Vajira Hosp
Bangkok, Thailand
Siriraj Hosp / Mahidol Univ
Bangkok, Thailand
Chiangmai Univ
Chiang Mai, Thailand
United Kingdom
King's College Hosp
Cambewell, United Kingdom
Saint James Hosp
Dublin, United Kingdom
Royal Free Hosp
London, United Kingdom
Venezuela
Hosp U de Caracas / Ciudad
Caracas, Venezuela
Hosp Vargas de Caracas
Caracas, Venezuela
Hosp Dr Domingo Luciani
Miranda, Venezuela
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00013897     History of Changes
Other Study ID Numbers: 302C, AI424-034
Study First Received: March 31, 2001
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Placebos
Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
BMS 232632
efavirenz

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atazanavir
Efavirenz
Lamivudine
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014