Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive
NCT ID: NCT01489046
Last Updated: 2016-04-15
Study Results
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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TERMINATED
PHASE2
297 participants
INTERVENTIONAL
2011-02-28
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
BMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
Placebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
BMS-986001
Capsules, Oral, 200 mg, Once daily, At least 48 weeks
Placebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
BMS-986001
Capsules, Oral, 400 mg, Once daily, At least 48 weeks
Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Tenofovir
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Interventions
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BMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
BMS-986001
Capsules, Oral, 200 mg, Once daily, At least 48 weeks
BMS-986001
Capsules, Oral, 400 mg, Once daily, At least 48 weeks
Placebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Tenofovir
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plasma HIV-1 RNA \> 5000 copies/mL
* Antiretroviral treatment-naive; defined as no current or previous exposure to \> 1 week of an antiretroviral drug
* CD4+ T-cell count \> 200 cells/mm3
Exclusion Criteria
* Contraindications to any of the study drugs
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Uc Davis Medical Center
Sacramento, California, United States
Orlando Immunology Center
Orlando, Florida, United States
Triple O Medical Services, P.A.
West Palm Beach, Florida, United States
Aids Research Consortium Of Atlanta
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Local Institution
Washingtondc, Maryland, United States
Clinic 42 And International Travel Clinic
Minneapolis, Minnesota, United States
University At Buffalo
Buffalo, New York, United States
Local Institution
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Local Institution
Charlotte, North Carolina, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Local Institution
Columbia, South Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
St. Hope Foundation
Bellaire, Texas, United States
North Texas Infectious Disease Consultants
Dallas, Texas, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States
Therapeutic Concepts, P.A.
Houston, Texas, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution
Darlinghurst, New South Wales, Australia
Local Institution
Liverpool, New South Wales, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Bogota, Cundinamarca, Colombia
Local Institution
Lyon, , France
Local Institution
Budapest, , Hungary
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Barranco, Lima region, Peru
Local Institution
San MartÃn de Porres, Lima region, Peru
Local Institution
Cercado, Lima, Peru
Local Institution
Iquitos, Loreto, Peru
Local Institution
Bloemfontein, Free State, South Africa
Local Institution
Johannesburg, Gauteng, South Africa
Local Institution
Soweto, Gauteng, South Africa
Local Institution
Dundee, KwaZulu-Natal, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Local Institution
Cape Town, , South Africa
Local Institution
Durban, , South Africa
Local Institution
Durban KZN, , South Africa
Local Institution
Badalona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Bangkok, , Thailand
Local Institution
Bangkok, , Thailand
Local Institution
Bangkok, , Thailand
Local Institution
Khon Kaen, , Thailand
Local Institution
Nontaburi, , Thailand
Countries
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References
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Gupta SK, McComsey GA, Lombaard J, Echevarria J, Orrell C, Avihingsanon A, Osiyemi O, Santoscoy M, Ray N, Stock DA, Joshi SR, Hanna GJ, Lataillade M. Efficacy, safety, bone and metabolic effects of HIV nucleoside reverse transcriptase inhibitor BMS-986001 (AI467003): a phase 2b randomised, controlled, partly blinded trial. Lancet HIV. 2016 Jan;3(1):e13-22. doi: 10.1016/S2352-3018(15)00231-3. Epub 2015 Dec 12.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-003329-89
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI467-003
Identifier Type: -
Identifier Source: org_study_id
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