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

NCT ID: NCT00013897

Last Updated: 2011-05-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2003-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atazanavir

Intervention Type DRUG

Lamivudine/Zidovudine

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Phoenix Body Positive

Phoenix, Arizona, United States

Site Status

Univ of Southern California

Los Angeles, California, United States

Site Status

Saint Francis Mem Hosp / HIV Care Unit

San Francisco, California, United States

Site Status

Dupont Circle Physicians Group

Washington D.C., District of Columbia, United States

Site Status

Dr Bruce Rashbaum

Washington D.C., District of Columbia, United States

Site Status

North Broward Hosp District / HIV Clinical Research

Fort Lauderdale, Florida, United States

Site Status

Associates in Research

Fort Myers, Florida, United States

Site Status

Steinhart Medical Associates

Miami, Florida, United States

Site Status

Saint Josephs Comprehensive Research Institute

Tampa, Florida, United States

Site Status

Emory Univ

Atlanta, Georgia, United States

Site Status

The CORE Ctr

Chicago, Illinois, United States

Site Status

Univ of Kansas School of Medicine

Wichita, Kansas, United States

Site Status

Univ of Michigan Hospitals and Health Ctrs

Ann Arbor, Michigan, United States

Site Status

Washington Univ School of Medicine

St Louis, Missouri, United States

Site Status

Univ of Nebraska Medical Ctr

Omaha, Nebraska, United States

Site Status

Robert Wood Johnson Med School/UMDNJ

New Brunswick, New Jersey, United States

Site Status

UMDNJ - New Jersey Med School

Newark, New Jersey, United States

Site Status

ID Care Inc

Somerville, New Jersey, United States

Site Status

Univ of NM

Albuquerque, New Mexico, United States

Site Status

Duke Univ Med Ctr / Infectious Disease Clinic

Durham, North Carolina, United States

Site Status

Jemsek Clinic

Huntersville, North Carolina, United States

Site Status

Ohio State Univ Hosp

Columbus, Ohio, United States

Site Status

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

Site Status

Julio Arroyo

West Columbia, South Carolina, United States

Site Status

Methodist Healthcare

Memphis, Tennessee, United States

Site Status

Oaklawn Physicians Group

Dallas, Texas, United States

Site Status

Tarrant County Infectious Diseases Associates

Fort Worth, Texas, United States

Site Status

Montrose Clinic

Houston, Texas, United States

Site Status

AKH Wien

Vienna, , Austria

Site Status

Pulmologisches Zentrum Der Stadt Wien

Vienna, , Austria

Site Status

CHU Saint Pierre

Brussels, , Belgium

Site Status

UZ Gasthuisberg

Leuven, , Belgium

Site Status

Univ of Alberta/Division of Inf Dis/Dept of Med

Edmonton, Alberta, Canada

Site Status

Univ of British Columbia

Vancouver, British Columbia, Canada

Site Status

McMaster Univ Med Ctr

Hamilton, Ontario, Canada

Site Status

Gary Rubin

Toronto, Ontario, Canada

Site Status

Fundacion Arriaran

Santiago, , Chile

Site Status

Hosp Clinico de La Pontificia Universidad Catolica de Chile

Santiago, , Chile

Site Status

Hosp Sotero de Rio

Santiago, , Chile

Site Status

Servicio de Dermatologia-Hosp del Salvador

Santiago, , Chile

Site Status

SEMECO

San José, , Costa Rica

Site Status

Hopital Hotel Dieu de Lyon

Lyon, , France

Site Status

CHU De Bicetre

Paris, , France

Site Status

Hopital Cochin - Port Royal

Paris, , France

Site Status

Services des Maladies Infectieuses

Paris, , France

Site Status

Hospital Gustave Dron

Tourcoing, , France

Site Status

Rheinische Friedrich Wilhelms Universitaet Medizinische

Bonn, , Germany

Site Status

Univ Zu Koeln

Cologne, , Germany

Site Status

Hosp General San Juan de Dios

Guatemala City, , Guatemala

Site Status

Hosp Roosevelt Chief Infectious Diseases Unit

Guatemala City, , Guatemala

Site Status

Saint Laszlo Hosp

Budapest, , Hungary

Site Status

Kaplan Med Ctr

Rehovot, , Israel

Site Status

Ospedale S Orsola

Bologna, , Italy

Site Status

Immunoligia Universita Cagliari

Cagliari, , Italy

Site Status

Ospedale Luigi Sacco Cargnel

Milan, , Italy

Site Status

Ospedale S Raffaele

Milan, , Italy

Site Status

Ospedale degli Infermi

Rimini, , Italy

Site Status

Cat All Immun Clin

Roma, , Italy

Site Status

Ospedale Amedeo de Savoia

Torino, , Italy

Site Status

Ospedale Amedeo di Savoia

Torino, , Italy

Site Status

Hosp Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status

Univ of Malaya Med Ctr

Kuala Lumpur, , Malaysia

Site Status

Consultorio Royal Ctr

Panama City, , Panama

Site Status

Hosp Edgardo Rebagliati

Lima, , Peru

Site Status

Hosp Guillermo Almenara-Medicina 1

Lima, , Peru

Site Status

Hosp Nacional Arzobispo Loayza-PROCETS

Lima, , Peru

Site Status

Hosp Nacional Cayetano Heredia

Lima, , Peru

Site Status

Hosp Nacional dos de Mayo

Lima, , Peru

Site Status

Hosp De Santa Maria

Lisbon, , Portugal

Site Status

Hosp De Sao Joao

Porto, , Portugal

Site Status

Clinical Research Puerto Rico Inc

San Juan, , Puerto Rico

Site Status

San Juan VAMC

San Juan, , Puerto Rico

Site Status

Federal AIDS Ctr

Moscow, , Russia

Site Status

Infectious Hosp 30

Saint Petersburg, , Russia

Site Status

Ust Izhora Fed Infectious Hosp

Saint Petersburg, , Russia

Site Status

Brooklyn Med Ctr

Cape Town, , South Africa

Site Status

Tygerberg Hosp

Cape Town, , South Africa

Site Status

Chris Hani Baragwanath Hosp

Johannesburg, , South Africa

Site Status

Toga Lab

Johannesburg, , South Africa

Site Status

Hosp Clinic

Barcelona, , Spain

Site Status

Hosp Germans Trias I Pujol

Barcelona, , Spain

Site Status

Hosp de Basurto / Enfermedades Infecciosas

Bilboa, , Spain

Site Status

Hosp Reina Sofia

Córdoba, , Spain

Site Status

Hosp Carlos III

Madrid, , Spain

Site Status

Hosp Ramon y Cajal

Madris, , Spain

Site Status

Hosp Nuestra Senora de Covadonga

Oviedo, , Spain

Site Status

Hosp Virgen Del Rocio

Seville, , Spain

Site Status

Universitatsspital Zurich

Zurich, , Switzerland

Site Status

Rajavithi Hosp

Bangkok, , Thailand

Site Status

Ramathibodi Hosp

Bangkok, , Thailand

Site Status

Siriraj Hosp / Mahidol Univ

Bangkok, , Thailand

Site Status

Vajira Hosp

Bangkok, , Thailand

Site Status

Chiangmai Univ

Chiang Mai, , Thailand

Site Status

King's College Hosp

Cambewell, , United Kingdom

Site Status

Saint James Hosp

Dublin, , United Kingdom

Site Status

Royal Free Hosp

London, , United Kingdom

Site Status

Hosp U de Caracas / Ciudad

Caracas, , Venezuela

Site Status

Hosp Vargas de Caracas

Caracas, , Venezuela

Site Status

Hosp Dr Domingo Luciani

Miranda, , Venezuela

Site Status

Countries

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United States Austria Belgium Canada Chile Costa Rica France Germany Guatemala Hungary Israel Italy Malaysia Panama Peru Portugal Puerto Rico Russia South Africa Spain Switzerland Thailand United Kingdom Venezuela

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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