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Home > "A" Clinical Trials Conditions > A Comparison of BMS-232632 with Efavirenz, Each in Combination with Zidovudine-Lamivudine

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



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

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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).
Details: 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:
Study Type:
  Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Ospedale degli Infermi
Rimini,  , 
Italy
 

Hosp Edgardo Rebagliati
Lima,  , 
Peru
 

Associates in Research
Ft. Myers,  Florida,  33901
United States
 

Chiangmai Univ
Chiang Mai,  , 
Thailand
 

Rajavithi Hosp
Bangkok,  , 
Thailand
 

Tygerberg Hosp
Cape Town,  , 
South Africa
 

Hosp Clinic
Barcelona,  , 
Spain
 

Kaplan Med Ctr
Rehovot,  , 
Israel
 

Infectious Hosp 30
St Petersburg,  , 
Russian Federation
 

Hosp Sotero de Rio
Santiago,  , 
Chile
 

ID Care Inc
Somerville,  New Jersey,  08876
United States
 

Hosp Vargas de Caracas
Caracas,  , 
Venezuela
 

Hosp Germans Trias I Pujol
Barcelona,  , 
Spain
 

Saint Laszlo Hosp
Budapest,  , 
Hungary
 

Vajira Hosp
Bangkok,  , 
Thailand
 

Gary Rubin
Toronto,  Ontario, 
Canada
 

Montrose Clinic
Houston,  Texas,  77006
United States
 

Duke Univ Med Ctr / Infectious Disease Clinic
Durham,  North Carolina,  27710
United States
 

Univ Zu Koeln
Koeln,  , 
Germany
 

Ospedale Amedeo di Savoia
Torino,  , 
Italy
 

Oaklawn Physicians Group
Dallas,  Texas,  75219
United States
 

Siriraj Hosp / Mahidol Univ
Bangkok,  , 
Thailand
 

Jemsek Clinic
Huntersville,  North Carolina,  28078
United States
 

Hosp Nuestra Senora de Covadonga
Oviedo,  , 
Spain
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

Services des Maladies Infectieuses
Paris Cedex 12,  , 
France
 

Emory Univ
Atlanta,  Georgia,  30308
United States
 

Royal Free Hosp
London,  , 
United Kingdom
 

Dr Bruce Rashbaum
Washington D.C.,  District of Columbia,  20037
United States
 

Ramathibodi Hosp
Bangkok,  , 
Thailand
 

Hosp Guillermo Almenara-Medicina 1
Lima,  , 
Peru
 

Servicio de Dermatologia-Hosp del Salvador
Santiago,  , 
Chile
 

Dupont Circle Physicians Group
Washington D.C.,  District of Columbia,  200091104
United States
 

San Juan VAMC
San Juan,  ,  009265800
Puerto Rico
 

Univ of Alberta/Division of Inf Dis/Dept of Med
Edmonton,  Alberta, 
Canada
 

Washington Univ School of Medicine
St. Louis,  Missouri,  63108
United States
 

CHU Saint Pierre
Brussels,  , 
Belgium
 

Saint James Hosp
Dublin,  , 
United Kingdom
 

Fundacion Arriaran
Santiago,  , 
Chile
 

Tarrant County Infectious Diseases Associates
Ft. Worth,  Texas,  76104
United States
 

Ohio State Univ Hosp
Columbus,  Ohio,  432101282
United States
 

Univ of British Columbia
Vancouver,  British Columbia, 
Canada
 

Immunoligia Universita Cagliari
Cagliari,  , 
Italy
 

Hosp Roosevelt Chief Infectious Diseases Unit
Guatemala,  , 
Guatemala
 

Univ of Michigan Hospitals and Health Ctrs
Ann Arbor,  Michigan,  481090378
United States
 

Univ of Malaya Med Ctr
Kuala Lumpur,  , 
Malaysia
 

Pulmologisches Zentrum Der Stadt Wien
Wien,  , 
Austria
 

Clinical Research Puerto Rico Inc
San Juan,  ,  009091711
Puerto Rico
 

Universitatsspital Zurich
Zurich,  , 
Switzerland
 

Ust Izhora Fed Infectious Hosp
St Petersburg,  , 
Russian Federation
 

Hosp Dr Domingo Luciani
Miranda,  , 
Venezuela
 

Methodist Healthcare
Memphis,  Tennessee,  38104
United States
 

Ospedale S Raffaele
Milano,  , 
Italy
 

Federal AIDS Ctr
Moscow,  , 
Russian Federation
 

Hopital Hotel Dieu de Lyon
Lyon,  , 
France
 

Phoenix Body Positive
Phoenix,  Arizona,  85006
United States
 

Univ of Kansas School of Medicine
Wichita,  Kansas,  672143124
United States
 

Univ of Southern California
Los Angeles,  California,  90033
United States
 

AKH Wien
Wien,  , 
Austria
 

Hosp General San Juan de Dios
Guatemala,  , 
Guatemala
 

Rheinische Friedrich Wilhelms Universitaet Medizinische
Bonn,  , 
Germany
 

North Broward Hosp District / HIV Clinical Research
Ft. Lauderdale,  Florida,  33311
United States
 

Ospedale Amedeo de Savoia
Torino,  , 
Italy
 

Philadelphia FIGHT
Philadelphia,  Pennsylvania,  19107
United States
 

Hosp Clinico de La Pontificia Universidad Catolica de Chile
Santiago,  , 
Chile
 

Hosp Virgen Del Rocio
Sevilla,  , 
Spain
 

The CORE Ctr
Chicago,  Illinois,  60612
United States
 

Steinhart Medical Associates
Miami,  Florida,  33133
United States
 

Hopital Cochin - Port Royal
Paris,  , 
France
 

Chris Hani Baragwanath Hosp
Johannesburg,  , 
South Africa
 

Saint Francis Mem Hosp / HIV Care Unit
San Francisco,  California,  94109
United States
 

Hosp De Sao Joao
Porto,  , 
Portugal
 

McMaster Univ Med Ctr
Hamilton,  Ontario, 
Canada
 

Toga Lab
Johannesburg,  , 
South Africa
 

Saint Josephs Comprehensive Research Institute
Tampa,  Florida,  33607
United States
 

Robert Wood Johnson Med School/UMDNJ
New Brunswick,  New Jersey,  089030019
United States
 

UMDNJ - New Jersey Med School
Newark,  New Jersey,  071032757
United States
 

Ospedale S Orsola
Bologna,  , 
Italy
 

King's College Hosp
Cambewell,  , 
United Kingdom
 

Hosp Ramon y Cajal
Madris,  , 
Spain
 

Hosp Reina Sofia
Cordoba,  , 
Spain
 

Hosp U de Caracas / Ciudad
Caracas,  , 
Venezuela
 

Hosp de Basurto / Enfermedades Infecciosas
Bilboa,  , 
Spain
 

Univ of NM
Albuquerque,  New Mexico,  87131
United States
 

Hosp Nacional Arzobispo Loayza-PROCETS
Lima,  , 
Peru
 

UZ Gasthuisberg
Leuven,  , 
Belgium
 

Ospedale Luigi Sacco Cargnel
Milano,  , 
Italy
 

Univ of Nebraska Medical Ctr
Omaha,  Nebraska,  681985400
United States
 

Brooklyn Med Ctr
Cape Town,  , 
South Africa
 

Cat All Immun Clin
Roma,  , 
Italy
 

Hosp Nacional dos de Mayo
Lima,  , 
Peru
 

Hosp De Santa Maria
Lisboa,  , 
Portugal
 

Hosp Carlos III
Madrid,  , 
Spain
 

Hosp Kuala Lumpur
Kuala Lumpur,  , 
Malaysia
 

Hospital Gustave Dron
Tourcoing,  , 
France
 

Hosp Nacional Cayetano Heredia
Lima,  , 
Peru
 

CHU De Bicetre
Paris,  , 
France
 

Consultorio Royal Ctr
Panama,  , 
Panama
 

SEMECO
San Jose,  , 
Costa Rica
 


Additional Information:
Study ID Numbers:
  302C;  AI424-034
Study Start Date: February 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013897

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

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