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

NCT00013897 | Completed Phase 3

• 2 other identifiers: 302CAI424-034
• Study Type: interventional
• Target: N/A
• Locations: 24 countries
• Sites: 99

Brief Summary

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).

Conditions

HIV Infections

Keywords

Placebos; Drug Therapy, Combination; Zidovudine; HIV Protease Inhibitors; Lamivudine; RNA, Viral; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; BMS 232632; efavirenz

Interventions

Atazanavir DRUG

Lamivudine/Zidovudine DRUG

Efavirenz DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (99)

Phoenix Body Positive

Phoenix, Arizona, 85006, United States

Location

Univ of Southern California

Los Angeles, California, 90033, United States

Location

Saint Francis Mem Hosp / HIV Care Unit

San Francisco, California, 94109, United States

Location

Dupont Circle Physicians Group

Washington D.C., District of Columbia, 200091104, United States

Location

Dr Bruce Rashbaum

Washington D.C., District of Columbia, 20037, United States

Location

North Broward Hosp District / HIV Clinical Research

Fort Lauderdale, Florida, 33311, United States

Location

Associates in Research

Fort Myers, Florida, 33901, United States

Location

Steinhart Medical Associates

Miami, Florida, 33133, United States

Location

Saint Josephs Comprehensive Research Institute

Tampa, Florida, 33607, United States

Location

Emory Univ

Atlanta, Georgia, 30308, United States

Location

The CORE Ctr

Chicago, Illinois, 60612, United States

Location

Univ of Kansas School of Medicine

Wichita, Kansas, 672143124, United States

Location

Univ of Michigan Hospitals and Health Ctrs

Ann Arbor, Michigan, 481090378, United States

Location

Washington Univ School of Medicine

St Louis, Missouri, 63108, United States

Location

Univ of Nebraska Medical Ctr

Omaha, Nebraska, 681985400, United States

Location

Robert Wood Johnson Med School/UMDNJ

New Brunswick, New Jersey, 089030019, United States

Location

UMDNJ - New Jersey Med School

Newark, New Jersey, 071032757, United States

Location

ID Care Inc

Somerville, New Jersey, 08876, United States

Location

Univ of NM

Albuquerque, New Mexico, 87131, United States

Location

Duke Univ Med Ctr / Infectious Disease Clinic

Durham, North Carolina, 27710, United States

Location

Jemsek Clinic

Huntersville, North Carolina, 28078, United States

Location

Ohio State Univ Hosp

Columbus, Ohio, 432101282, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Methodist Healthcare

Memphis, Tennessee, 38104, United States

Location

Oaklawn Physicians Group

Dallas, Texas, 75219, United States

Location

Tarrant County Infectious Diseases Associates

Fort Worth, Texas, 76104, United States

Location

Montrose Clinic

Houston, Texas, 77006, United States

Location

AKH Wien

Vienna, Austria

Location

Pulmologisches Zentrum Der Stadt Wien

Vienna, Austria

Location

CHU Saint Pierre

Brussels, Belgium

Location

UZ Gasthuisberg

Leuven, Belgium

Location

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

Edmonton, Alberta, Canada

Location

Univ of British Columbia

Vancouver, British Columbia, Canada

Location

McMaster Univ Med Ctr

Hamilton, Ontario, Canada

Location

Gary Rubin

Toronto, Ontario, Canada

Location

Fundacion Arriaran

Santiago, Chile

Location

Hosp Clinico de La Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

Hosp Sotero de Rio

Santiago, Chile

Location

Servicio de Dermatologia-Hosp del Salvador

Santiago, Chile

Location

SEMECO

San José, Costa Rica

Location

Hopital Hotel Dieu de Lyon

Lyon, France

Location

CHU De Bicetre

Paris, France

Location

Hopital Cochin - Port Royal

Paris, France

Location

Services des Maladies Infectieuses

Paris, France

Location

Hospital Gustave Dron

Tourcoing, France

Location

Rheinische Friedrich Wilhelms Universitaet Medizinische

Bonn, Germany

Location

Univ Zu Koeln

Cologne, Germany

Location

Hosp General San Juan de Dios

Guatemala City, Guatemala

Location

Hosp Roosevelt Chief Infectious Diseases Unit

Guatemala City, Guatemala

Location

Saint Laszlo Hosp

Budapest, Hungary

Location

Kaplan Med Ctr

Rehovot, Israel

Location

Ospedale S Orsola

Bologna, Italy

Location

Immunoligia Universita Cagliari

Cagliari, Italy

Location

Ospedale Luigi Sacco Cargnel

Milan, Italy

Location

Ospedale S Raffaele

Milan, Italy

Location

Ospedale degli Infermi

Rimini, Italy

Location

Cat All Immun Clin

Roma, Italy

Location

Ospedale Amedeo de Savoia

Torino, Italy

Location

Ospedale Amedeo di Savoia

Torino, Italy

Location

Hosp Kuala Lumpur

Kuala Lumpur, Malaysia

Location

Univ of Malaya Med Ctr

Kuala Lumpur, Malaysia

Location

Consultorio Royal Ctr

Panama City, Panama

Location

Hosp Edgardo Rebagliati

Lima, Peru

Location

Hosp Guillermo Almenara-Medicina 1

Lima, Peru

Location

Hosp Nacional Arzobispo Loayza-PROCETS

Lima, Peru

Location

Hosp Nacional Cayetano Heredia

Lima, Peru

Location

Hosp Nacional dos de Mayo

Lima, Peru

Location

Hosp De Santa Maria

Lisbon, Portugal

Location

Hosp De Sao Joao

Porto, Portugal

Location

Clinical Research Puerto Rico Inc

San Juan, 009091711, Puerto Rico

Location

San Juan VAMC

San Juan, 009265800, Puerto Rico

Location

Federal AIDS Ctr

Moscow, Russia

Location

Infectious Hosp 30

Saint Petersburg, Russia

Location

Ust Izhora Fed Infectious Hosp

Saint Petersburg, Russia

Location

Brooklyn Med Ctr

Cape Town, South Africa

Location

Tygerberg Hosp

Cape Town, South Africa

Location

Chris Hani Baragwanath Hosp

Johannesburg, South Africa

Location

Toga Lab

Johannesburg, South Africa

Location

Hosp Clinic

Barcelona, Spain

Location

Hosp Germans Trias I Pujol

Barcelona, Spain

Location

Hosp de Basurto / Enfermedades Infecciosas

Bilboa, Spain

Location

Hosp Reina Sofia

Córdoba, Spain

Location

Hosp Carlos III

Madrid, Spain

Location

Hosp Ramon y Cajal

Madris, Spain

Location

Hosp Nuestra Senora de Covadonga

Oviedo, Spain

Location

Hosp Virgen Del Rocio

Seville, Spain

Location

Universitatsspital Zurich

Zurich, Switzerland

Location

Rajavithi Hosp

Bangkok, Thailand

Location

Ramathibodi Hosp

Bangkok, Thailand

Location

Siriraj Hosp / Mahidol Univ

Bangkok, Thailand

Location

Vajira Hosp

Bangkok, Thailand

Location

Chiangmai Univ

Chiang Mai, Thailand

Location

King's College Hosp

Cambewell, United Kingdom

Location

Saint James Hosp

Dublin, United Kingdom

Location

Royal Free Hosp

London, United Kingdom

Location

Hosp U de Caracas / Ciudad

Caracas, Venezuela

Location

Hosp Vargas de Caracas

Caracas, Venezuela

Location

Hosp Dr Domingo Luciani

Miranda, Venezuela

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate; lamivudine, zidovudine drug combination; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2001
• First Posted: August 31, 2001
• Study Start: February 1, 2001
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2003
• Last Updated: May 4, 2011

Record last verified: 2011-04

Locations

DE (2); CL (4); FR (5); IT (8); ZA (4); BE (2); PR (2); CH (1); PA (1); PE (5); PT (2); IL (1); ES (8); VE (3); RU (3); TH (5); CA (4); AU (2); CO (1); US (28); GU (2); HU (1); MY (2); GB (3)