A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine
NCT ID: NCT00013897
Last Updated: 2011-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2001-02-28
2003-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Atazanavir
Lamivudine/Zidovudine
Efavirenz
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Locations
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Phoenix Body Positive
Phoenix, Arizona, United States
Univ of Southern California
Los Angeles, California, United States
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Dr Bruce Rashbaum
Washington D.C., District of Columbia, United States
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, United States
Associates in Research
Fort Myers, Florida, United States
Steinhart Medical Associates
Miami, Florida, United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, United States
Emory Univ
Atlanta, Georgia, United States
The CORE Ctr
Chicago, Illinois, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, United States
Washington Univ School of Medicine
St Louis, Missouri, United States
Univ of Nebraska Medical Ctr
Omaha, Nebraska, United States
Robert Wood Johnson Med School/UMDNJ
New Brunswick, New Jersey, United States
UMDNJ - New Jersey Med School
Newark, New Jersey, United States
ID Care Inc
Somerville, New Jersey, United States
Univ of NM
Albuquerque, New Mexico, United States
Duke Univ Med Ctr / Infectious Disease Clinic
Durham, North Carolina, United States
Jemsek Clinic
Huntersville, North Carolina, United States
Ohio State Univ Hosp
Columbus, Ohio, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, United States
Methodist Healthcare
Memphis, Tennessee, United States
Oaklawn Physicians Group
Dallas, Texas, United States
Tarrant County Infectious Diseases Associates
Fort Worth, Texas, United States
Montrose Clinic
Houston, Texas, United States
AKH Wien
Vienna, , Austria
Pulmologisches Zentrum Der Stadt Wien
Vienna, , Austria
CHU Saint Pierre
Brussels, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
Univ of Alberta/Division of Inf Dis/Dept of Med
Edmonton, Alberta, Canada
Univ of British Columbia
Vancouver, British Columbia, Canada
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Gary Rubin
Toronto, Ontario, Canada
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 José, , Costa Rica
Hopital Hotel Dieu de Lyon
Lyon, , France
CHU De Bicetre
Paris, , France
Hopital Cochin - Port Royal
Paris, , France
Services des Maladies Infectieuses
Paris, , France
Hospital Gustave Dron
Tourcoing, , France
Rheinische Friedrich Wilhelms Universitaet Medizinische
Bonn, , Germany
Univ Zu Koeln
Cologne, , Germany
Hosp General San Juan de Dios
Guatemala City, , Guatemala
Hosp Roosevelt Chief Infectious Diseases Unit
Guatemala City, , 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
Milan, , Italy
Ospedale S Raffaele
Milan, , 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 City, , 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
Lisbon, , Portugal
Hosp De Sao Joao
Porto, , Portugal
Clinical Research Puerto Rico Inc
San Juan, , Puerto Rico
San Juan VAMC
San Juan, , Puerto Rico
Federal AIDS Ctr
Moscow, , Russia
Infectious Hosp 30
Saint Petersburg, , Russia
Ust Izhora Fed Infectious Hosp
Saint Petersburg, , Russia
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
Córdoba, , Spain
Hosp Carlos III
Madrid, , Spain
Hosp Ramon y Cajal
Madris, , Spain
Hosp Nuestra Senora de Covadonga
Oviedo, , Spain
Hosp Virgen Del Rocio
Seville, , 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
Countries
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Other Identifiers
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AI424-034
Identifier Type: -
Identifier Source: secondary_id
302C
Identifier Type: -
Identifier Source: org_study_id
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