Clinical trial NCT00013897: A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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).

Detailed description: 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Body Positive
state: Arizona
city: Los Angeles
country: United States
facility: Univ of Southern California
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp / HIV Care Unit
state: California
city: Washington
country: United States
facility: Dupont Circle Physicians Group
state: District of Columbia
city: Washington
country: United States
facility: Dr Bruce Rashbaum
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: North Broward Hosp District / HIV Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: Associates in Research
state: Florida
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
city: Tampa
country: United States
facility: Saint Josephs Comprehensive Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Univ
state: Georgia
city: Chicago
country: United States
facility: The CORE Ctr
state: Illinois
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: Ann Arbor
country: United States
facility: Univ of Michigan Hospitals and Health Ctrs
state: Michigan
city: St Louis
country: United States
facility: Washington Univ School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Univ of Nebraska Medical Ctr
state: Nebraska
city: New Brunswick
country: United States
facility: Robert Wood Johnson Med School/UMDNJ
state: New Jersey
city: Newark
country: United States
facility: UMDNJ - New Jersey Med School
state: New Jersey
city: Somerville
country: United States
facility: ID Care Inc
state: New Jersey
city: Albuquerque
country: United States
facility: Univ of NM
state: New Mexico
city: Durham
country: United States
facility: Duke Univ Med Ctr / Infectious Disease Clinic
state: North Carolina
city: Huntersville
country: United States
facility: Jemsek Clinic
state: North Carolina
city: Columbus
country: United States
facility: Ohio State Univ Hosp
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: West Columbia
country: United States
facility: Julio Arroyo
state: South Carolina
city: Memphis
country: United States
facility: Methodist Healthcare
state: Tennessee
city: Dallas
country: United States
facility: Oaklawn Physicians Group
state: Texas
city: Fort Worth
country: United States
facility: Tarrant County Infectious Diseases Associates
state: Texas
city: Houston
country: United States
facility: Montrose Clinic
state: Texas
city: Wien
country: Austria
facility: AKH Wien
city: Wien
country: Austria
facility: Pulmologisches Zentrum Der Stadt Wien
city: Brussels
country: Belgium
facility: CHU Saint Pierre
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Edmonton
country: Canada
facility: Univ of Alberta/Division of Inf Dis/Dept of Med
state: Alberta
city: Vancouver
country: Canada
facility: Univ of British Columbia
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster Univ Med Ctr
state: Ontario
city: Toronto
country: Canada
facility: Gary Rubin
state: Ontario
city: Santiago
country: Chile
facility: Fundacion Arriaran
city: Santiago
country: Chile
facility: Hosp Clinico de La Pontificia Universidad Catolica de Chile
city: Santiago
country: Chile
facility: Hosp Sotero de Rio
city: Santiago
country: Chile
facility: Servicio de Dermatologia-Hosp del Salvador
city: San Jose
country: Costa Rica
facility: SEMECO
city: Lyon
country: France
facility: Hopital Hotel Dieu de Lyon
city: Paris Cedex 12
country: France
facility: Services des Maladies Infectieuses
city: Paris
country: France
facility: CHU De Bicetre
city: Paris
country: France
facility: Hopital Cochin - Port Royal
city: Tourcoing
country: France
facility: Hospital Gustave Dron
city: Bonn
country: Germany
facility: Rheinische Friedrich Wilhelms Universitaet Medizinische
city: Koeln
country: Germany
facility: Univ Zu Koeln
city: Guatemala
country: Guatemala
facility: Hosp General San Juan de Dios
city: Guatemala
country: Guatemala
facility: Hosp Roosevelt Chief Infectious Diseases Unit
city: Budapest
country: Hungary
facility: Saint Laszlo Hosp
city: Rehovot
country: Israel
facility: Kaplan Med Ctr
city: Bologna
country: Italy
facility: Ospedale S Orsola
city: Cagliari
country: Italy
facility: Immunoligia Universita Cagliari
city: Milano
country: Italy
facility: Ospedale Luigi Sacco Cargnel
city: Milano
country: Italy
facility: Ospedale S Raffaele
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Roma
country: Italy
facility: Cat All Immun Clin
city: Torino
country: Italy
facility: Ospedale Amedeo de Savoia
city: Torino
country: Italy
facility: Ospedale Amedeo di Savoia
city: Kuala Lumpur
country: Malaysia
facility: Hosp Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Univ of Malaya Med Ctr
city: Panama
country: Panama
facility: Consultorio Royal Ctr
city: Lima
country: Peru
facility: Hosp Edgardo Rebagliati
city: Lima
country: Peru
facility: Hosp Guillermo Almenara-Medicina 1
city: Lima
country: Peru
facility: Hosp Nacional Arzobispo Loayza-PROCETS
city: Lima
country: Peru
facility: Hosp Nacional Cayetano Heredia
city: Lima
country: Peru
facility: Hosp Nacional dos de Mayo
city: Lisboa
country: Portugal
facility: Hosp De Santa Maria
city: Porto
country: Portugal
facility: Hosp De Sao Joao
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico Inc
city: San Juan
country: Puerto Rico
facility: San Juan VAMC
city: Moscow
country: Russian Federation
facility: Federal AIDS Ctr
city: St Petersburg
country: Russian Federation
facility: Infectious Hosp 30
city: St Petersburg
country: Russian Federation
facility: Ust Izhora Fed Infectious Hosp
city: Cape Town
country: South Africa
facility: Brooklyn Med Ctr
city: Cape Town
country: South Africa
facility: Tygerberg Hosp
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hosp
city: Johannesburg
country: South Africa
facility: Toga Lab
city: Barcelona
country: Spain
facility: Hosp Clinic
city: Barcelona
country: Spain
facility: Hosp Germans Trias I Pujol
city: Bilboa
country: Spain
facility: Hosp de Basurto / Enfermedades Infecciosas
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Madrid
country: Spain
facility: Hosp Carlos III
city: Madris
country: Spain
facility: Hosp Ramon y Cajal
city: Oviedo
country: Spain
facility: Hosp Nuestra Senora de Covadonga
city: Sevilla
country: Spain
facility: Hosp Virgen Del Rocio
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
city: Bangkok
country: Thailand
facility: Rajavithi Hosp
city: Bangkok
country: Thailand
facility: Ramathibodi Hosp
city: Bangkok
country: Thailand
facility: Siriraj Hosp / Mahidol Univ
city: Bangkok
country: Thailand
facility: Vajira Hosp
city: Chiang Mai
country: Thailand
facility: Chiangmai Univ
city: Cambewell
country: United Kingdom
facility: King's College Hosp
city: Dublin
country: United Kingdom
facility: Saint James Hosp
city: London
country: United Kingdom
facility: Royal Free Hosp
city: Caracas
country: Venezuela
facility: Hosp U de Caracas / Ciudad
city: Caracas
country: Venezuela
facility: Hosp Vargas de Caracas
city: Miranda
country: Venezuela
facility: Hosp Dr Domingo Luciani
Study officials:
References: