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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00013897 |
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 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 |
Eligibility| 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:
Contacts and Locations
Hide Study 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 | |
| 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 | |
More Information
| 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 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 |