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Sponsored by: |
Bristol-Myers Squibb |
---|---|
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00013897 |
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 III |
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 |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
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 | |
Steinhart Medical Associates | |
Miami, Florida, United States, 33133 | |
Associates in Research | |
Fort Myers, Florida, United States, 33901 | |
Saint Josephs Comprehensive Research Institute | |
Tampa, Florida, United States, 33607 | |
North Broward Hosp District / HIV Clinical Research | |
Fort Lauderdale, Florida, United States, 33311 | |
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 | |
Montrose Clinic | |
Houston, Texas, United States, 77006 | |
Tarrant County Infectious Diseases Associates | |
Fort Worth, Texas, United States, 76104 | |
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 degli Infermi | |
Rimini, Italy | |
Ospedale Luigi Sacco Cargnel | |
Milano, Italy | |
Ospedale S Orsola | |
Bologna, 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, Puerto Rico, 009265800 | |
Clinical Research Puerto Rico Inc | |
San Juan, Puerto Rico, 009091711 | |
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 Nuestra Senora de Covadonga | |
Oviedo, 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 Carlos III | |
Madrid, 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 |
Study ID Numbers: | 302C, AI424-034 |
Study First Received: | March 31, 2001 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00013897 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Placebos Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine RNA, Viral |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load BMS 232632 efavirenz |
Antimetabolites Efavirenz HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Atazanavir |
Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Atazanavir Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |