HIV Infections Clinical Trial
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
| Verified date | April 2011 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | April 2003 |
| Est. primary completion date | April 2003 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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. |
Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | AKH Wien | Wien | |
| Austria | Pulmologisches Zentrum Der Stadt Wien | Wien | |
| Belgium | CHU Saint Pierre | Brussels | |
| Belgium | UZ Gasthuisberg | Leuven | |
| Canada | Univ of Alberta/Division of Inf Dis/Dept of Med | Edmonton | Alberta |
| Canada | McMaster Univ Med Ctr | Hamilton | Ontario |
| Canada | Gary Rubin | Toronto | Ontario |
| Canada | Univ of British Columbia | Vancouver | British Columbia |
| Chile | 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 | |
| Costa Rica | SEMECO | San Jose | |
| France | Hopital Hotel Dieu de Lyon | Lyon | |
| France | CHU De Bicetre | Paris | |
| France | Hopital Cochin - Port Royal | Paris | |
| France | Services des Maladies Infectieuses | Paris Cedex 12 | |
| France | Hospital Gustave Dron | Tourcoing | |
| Germany | Rheinische Friedrich Wilhelms Universitaet Medizinische | Bonn | |
| Germany | Univ Zu Koeln | Koeln | |
| Guatemala | Hosp General San Juan de Dios | Guatemala | |
| Guatemala | Hosp Roosevelt Chief Infectious Diseases Unit | Guatemala | |
| Hungary | Saint Laszlo Hosp | Budapest | |
| Israel | Kaplan Med Ctr | Rehovot | |
| Italy | Ospedale S Orsola | Bologna | |
| Italy | Immunoligia Universita Cagliari | Cagliari | |
| Italy | Ospedale Luigi Sacco Cargnel | Milano | |
| Italy | Ospedale S Raffaele | Milano | |
| Italy | Ospedale degli Infermi | Rimini | |
| Italy | Cat All Immun Clin | Roma | |
| Italy | Ospedale Amedeo de Savoia | Torino | |
| Italy | Ospedale Amedeo di Savoia | Torino | |
| Malaysia | Hosp Kuala Lumpur | Kuala Lumpur | |
| Malaysia | Univ of Malaya Med Ctr | Kuala Lumpur | |
| Panama | Consultorio Royal Ctr | Panama | |
| Peru | 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 | |
| Portugal | Hosp De Santa Maria | Lisboa | |
| Portugal | Hosp De Sao Joao | Porto | |
| Puerto Rico | Clinical Research Puerto Rico Inc | San Juan | |
| Puerto Rico | San Juan VAMC | San Juan | |
| Russian Federation | Federal AIDS Ctr | Moscow | |
| Russian Federation | Infectious Hosp 30 | St Petersburg | |
| Russian Federation | Ust Izhora Fed Infectious Hosp | St Petersburg | |
| South Africa | Brooklyn Med Ctr | Cape Town | |
| South Africa | Tygerberg Hosp | Cape Town | |
| South Africa | Chris Hani Baragwanath Hosp | Johannesburg | |
| South Africa | Toga Lab | Johannesburg | |
| 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 | |
| Switzerland | Universitatsspital Zurich | Zurich | |
| Thailand | Rajavithi Hosp | Bangkok | |
| Thailand | Ramathibodi Hosp | Bangkok | |
| Thailand | Siriraj Hosp / Mahidol Univ | Bangkok | |
| Thailand | Vajira Hosp | Bangkok | |
| Thailand | Chiangmai Univ | Chiang Mai | |
| United Kingdom | King's College Hosp | Cambewell | |
| United Kingdom | Saint James Hosp | Dublin | |
| United Kingdom | Royal Free Hosp | London | |
| United States | Univ of NM | Albuquerque | New Mexico |
| United States | Univ of Michigan Hospitals and Health Ctrs | Ann Arbor | Michigan |
| United States | Emory Univ | Atlanta | Georgia |
| United States | The CORE Ctr | Chicago | Illinois |
| United States | Ohio State Univ Hosp | Columbus | Ohio |
| United States | Oaklawn Physicians Group | Dallas | Texas |
| United States | Duke Univ Med Ctr / Infectious Disease Clinic | Durham | North Carolina |
| United States | North Broward Hosp District / HIV Clinical Research | Fort Lauderdale | Florida |
| United States | Associates in Research | Fort Myers | Florida |
| United States | Tarrant County Infectious Diseases Associates | Fort Worth | Texas |
| United States | Montrose Clinic | Houston | Texas |
| United States | Jemsek Clinic | Huntersville | North Carolina |
| United States | Univ of Southern California | Los Angeles | California |
| United States | Methodist Healthcare | Memphis | Tennessee |
| United States | Steinhart Medical Associates | Miami | Florida |
| United States | Robert Wood Johnson Med School/UMDNJ | New Brunswick | New Jersey |
| United States | UMDNJ - New Jersey Med School | Newark | New Jersey |
| United States | Univ of Nebraska Medical Ctr | Omaha | Nebraska |
| United States | Philadelphia FIGHT | Philadelphia | Pennsylvania |
| United States | Phoenix Body Positive | Phoenix | Arizona |
| United States | Saint Francis Mem Hosp / HIV Care Unit | San Francisco | California |
| United States | ID Care Inc | Somerville | New Jersey |
| United States | Washington Univ School of Medicine | St Louis | Missouri |
| United States | Saint Josephs Comprehensive Research Institute | Tampa | Florida |
| United States | Dr Bruce Rashbaum | Washington | District of Columbia |
| United States | Dupont Circle Physicians Group | Washington | District of Columbia |
| United States | Julio Arroyo | West Columbia | South Carolina |
| United States | Univ of Kansas School of Medicine | Wichita | Kansas |
| Venezuela | Hosp U de Caracas / Ciudad | Caracas | |
| Venezuela | Hosp Vargas de Caracas | Caracas | |
| Venezuela | Hosp Dr Domingo Luciani | Miranda |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Venezuela, Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Guatemala, Hungary, Israel, Italy, Malaysia, Panama, Peru, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Switzerland, Thailand, United Kingdom,
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