Back to resultsA Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atazanavir
Lamivudine/Zidovudine
Efavirenz
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Placebos, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, BMS 232632, efavirenz
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.
Sites / Locations
- Phoenix Body Positive
- Univ of Southern California
- Saint Francis Mem Hosp / HIV Care Unit
- Dupont Circle Physicians Group
- Dr Bruce Rashbaum
- North Broward Hosp District / HIV Clinical Research
- Associates in Research
- Steinhart Medical Associates
- Saint Josephs Comprehensive Research Institute
- Emory Univ
- The CORE Ctr
- Univ of Kansas School of Medicine
- Univ of Michigan Hospitals and Health Ctrs
- Washington Univ School of Medicine
- Univ of Nebraska Medical Ctr
- Robert Wood Johnson Med School/UMDNJ
- UMDNJ - New Jersey Med School
- ID Care Inc
- Univ of NM
- Duke Univ Med Ctr / Infectious Disease Clinic
- Jemsek Clinic
- Ohio State Univ Hosp
- Philadelphia FIGHT
- Julio Arroyo
- Methodist Healthcare
- Oaklawn Physicians Group
- Tarrant County Infectious Diseases Associates
- Montrose Clinic
- AKH Wien
- Pulmologisches Zentrum Der Stadt Wien
- CHU Saint Pierre
- UZ Gasthuisberg
- Univ of Alberta/Division of Inf Dis/Dept of Med
- Univ of British Columbia
- McMaster Univ Med Ctr
- Gary Rubin
- Fundacion Arriaran
- Hosp Clinico de La Pontificia Universidad Catolica de Chile
- Hosp Sotero de Rio
- Servicio de Dermatologia-Hosp del Salvador
- SEMECO
- Hopital Hotel Dieu de Lyon
- Services des Maladies Infectieuses
- CHU De Bicetre
- Hopital Cochin - Port Royal
- Hospital Gustave Dron
- Rheinische Friedrich Wilhelms Universitaet Medizinische
- Univ Zu Koeln
- Hosp General San Juan de Dios
- Hosp Roosevelt Chief Infectious Diseases Unit
- Saint Laszlo Hosp
- Kaplan Med Ctr
- Ospedale S Orsola
- Immunoligia Universita Cagliari
- Ospedale Luigi Sacco Cargnel
- Ospedale S Raffaele
- Ospedale degli Infermi
- Cat All Immun Clin
- Ospedale Amedeo de Savoia
- Ospedale Amedeo di Savoia
- Hosp Kuala Lumpur
- Univ of Malaya Med Ctr
- Consultorio Royal Ctr
- Hosp Edgardo Rebagliati
- Hosp Guillermo Almenara-Medicina 1
- Hosp Nacional Arzobispo Loayza-PROCETS
- Hosp Nacional Cayetano Heredia
- Hosp Nacional dos de Mayo
- Hosp De Santa Maria
- Hosp De Sao Joao
- Clinical Research Puerto Rico Inc
- San Juan VAMC
- Federal AIDS Ctr
- Infectious Hosp 30
- Ust Izhora Fed Infectious Hosp
- Brooklyn Med Ctr
- Tygerberg Hosp
- Chris Hani Baragwanath Hosp
- Toga Lab
- Hosp Clinic
- Hosp Germans Trias I Pujol
- Hosp de Basurto / Enfermedades Infecciosas
- Hosp Reina Sofia
- Hosp Carlos III
- Hosp Ramon y Cajal
- Hosp Nuestra Senora de Covadonga
- Hosp Virgen Del Rocio
- Universitatsspital Zurich
- Rajavithi Hosp
- Ramathibodi Hosp
- Siriraj Hosp / Mahidol Univ
- Vajira Hosp
- Chiangmai Univ
- King's College Hosp
- Saint James Hosp
- Royal Free Hosp
- Hosp U de Caracas / Ciudad
- Hosp Vargas de Caracas
- Hosp Dr Domingo Luciani
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00013897
Brief Title
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
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atazanavir
Intervention Type
Drug
Intervention Name(s)
Lamivudine/Zidovudine
Intervention Type
Drug
Intervention Name(s)
Efavirenz
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Univ of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Saint Francis Mem Hosp / HIV Care Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
Dr Bruce Rashbaum
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
North Broward Hosp District / HIV Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Associates in Research
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Steinhart Medical Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Saint Josephs Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Emory Univ
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
The CORE Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
672143124
Country
United States
Facility Name
Univ of Michigan Hospitals and Health Ctrs
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
481090378
Country
United States
Facility Name
Washington Univ School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Univ of Nebraska Medical Ctr
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985400
Country
United States
Facility Name
Robert Wood Johnson Med School/UMDNJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
089030019
Country
United States
Facility Name
UMDNJ - New Jersey Med School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032757
Country
United States
Facility Name
ID Care Inc
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Univ of NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Duke Univ Med Ctr / Infectious Disease Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Jemsek Clinic
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Ohio State Univ Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101282
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Methodist Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Oaklawn Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Tarrant County Infectious Diseases Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Montrose Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
AKH Wien
City
Wien
Country
Austria
Facility Name
Pulmologisches Zentrum Der Stadt Wien
City
Wien
Country
Austria
Facility Name
CHU Saint Pierre
City
Brussels
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Univ of Alberta/Division of Inf Dis/Dept of Med
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Univ of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
McMaster Univ Med Ctr
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Gary Rubin
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Fundacion Arriaran
City
Santiago
Country
Chile
Facility Name
Hosp Clinico de La Pontificia Universidad Catolica de Chile
City
Santiago
Country
Chile
Facility Name
Hosp Sotero de Rio
City
Santiago
Country
Chile
Facility Name
Servicio de Dermatologia-Hosp del Salvador
City
Santiago
Country
Chile
Facility Name
SEMECO
City
San Jose
Country
Costa Rica
Facility Name
Hopital Hotel Dieu de Lyon
City
Lyon
Country
France
Facility Name
Services des Maladies Infectieuses
City
Paris Cedex 12
Country
France
Facility Name
CHU De Bicetre
City
Paris
Country
France
Facility Name
Hopital Cochin - Port Royal
City
Paris
Country
France
Facility Name
Hospital Gustave Dron
City
Tourcoing
Country
France
Facility Name
Rheinische Friedrich Wilhelms Universitaet Medizinische
City
Bonn
Country
Germany
Facility Name
Univ Zu Koeln
City
Koeln
Country
Germany
Facility Name
Hosp General San Juan de Dios
City
Guatemala
Country
Guatemala
Facility Name
Hosp Roosevelt Chief Infectious Diseases Unit
City
Guatemala
Country
Guatemala
Facility Name
Saint Laszlo Hosp
City
Budapest
Country
Hungary
Facility Name
Kaplan Med Ctr
City
Rehovot
Country
Israel
Facility Name
Ospedale S Orsola
City
Bologna
Country
Italy
Facility Name
Immunoligia Universita Cagliari
City
Cagliari
Country
Italy
Facility Name
Ospedale Luigi Sacco Cargnel
City
Milano
Country
Italy
Facility Name
Ospedale S Raffaele
City
Milano
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
Country
Italy
Facility Name
Cat All Immun Clin
City
Roma
Country
Italy
Facility Name
Ospedale Amedeo de Savoia
City
Torino
Country
Italy
Facility Name
Ospedale Amedeo di Savoia
City
Torino
Country
Italy
Facility Name
Hosp Kuala Lumpur
City
Kuala Lumpur
Country
Malaysia
Facility Name
Univ of Malaya Med Ctr
City
Kuala Lumpur
Country
Malaysia
Facility Name
Consultorio Royal Ctr
City
Panama
Country
Panama
Facility Name
Hosp Edgardo Rebagliati
City
Lima
Country
Peru
Facility Name
Hosp Guillermo Almenara-Medicina 1
City
Lima
Country
Peru
Facility Name
Hosp Nacional Arzobispo Loayza-PROCETS
City
Lima
Country
Peru
Facility Name
Hosp Nacional Cayetano Heredia
City
Lima
Country
Peru
Facility Name
Hosp Nacional dos de Mayo
City
Lima
Country
Peru
Facility Name
Hosp De Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Hosp De Sao Joao
City
Porto
Country
Portugal
Facility Name
Clinical Research Puerto Rico Inc
City
San Juan
ZIP/Postal Code
009091711
Country
Puerto Rico
Facility Name
San Juan VAMC
City
San Juan
ZIP/Postal Code
009265800
Country
Puerto Rico
Facility Name
Federal AIDS Ctr
City
Moscow
Country
Russian Federation
Facility Name
Infectious Hosp 30
City
St Petersburg
Country
Russian Federation
Facility Name
Ust Izhora Fed Infectious Hosp
City
St Petersburg
Country
Russian Federation
Facility Name
Brooklyn Med Ctr
City
Cape Town
Country
South Africa
Facility Name
Tygerberg Hosp
City
Cape Town
Country
South Africa
Facility Name
Chris Hani Baragwanath Hosp
City
Johannesburg
Country
South Africa
Facility Name
Toga Lab
City
Johannesburg
Country
South Africa
Facility Name
Hosp Clinic
City
Barcelona
Country
Spain
Facility Name
Hosp Germans Trias I Pujol
City
Barcelona
Country
Spain
Facility Name
Hosp de Basurto / Enfermedades Infecciosas
City
Bilboa
Country
Spain
Facility Name
Hosp Reina Sofia
City
Cordoba
Country
Spain
Facility Name
Hosp Carlos III
City
Madrid
Country
Spain
Facility Name
Hosp Ramon y Cajal
City
Madris
Country
Spain
Facility Name
Hosp Nuestra Senora de Covadonga
City
Oviedo
Country
Spain
Facility Name
Hosp Virgen Del Rocio
City
Sevilla
Country
Spain
Facility Name
Universitatsspital Zurich
City
Zurich
Country
Switzerland
Facility Name
Rajavithi Hosp
City
Bangkok
Country
Thailand
Facility Name
Ramathibodi Hosp
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hosp / Mahidol Univ
City
Bangkok
Country
Thailand
Facility Name
Vajira Hosp
City
Bangkok
Country
Thailand
Facility Name
Chiangmai Univ
City
Chiang Mai
Country
Thailand
Facility Name
King's College Hosp
City
Cambewell
Country
United Kingdom
Facility Name
Saint James Hosp
City
Dublin
Country
United Kingdom
Facility Name
Royal Free Hosp
City
London
Country
United Kingdom
Facility Name
Hosp U de Caracas / Ciudad
City
Caracas
Country
Venezuela
Facility Name
Hosp Vargas de Caracas
City
Caracas
Country
Venezuela
Facility Name
Hosp Dr Domingo Luciani
City
Miranda
Country
Venezuela
12. IPD Sharing Statement
Learn more about this trial
A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine
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