Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive

Stopped early · Phase 2 · Has a placebo group

Conditions studied: HIV-1 Infection

In brief

The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

Key facts

Study ID

NCT01489046

Run by

Bristol-Myers Squibb

People needed

297

Starts

2011-02-01

Expected to finish

2014-07-01

Last updated by the study team

2016-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher)
• 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

You may not qualify if…

• Resistance to any of the study medications [Tenofovir Disoproxil Fumarate(TDF), Efavirenz (EFV), Lamivudine (3TC)] or to HIV Protease Inhibitors (PIs)
• Contraindications to any of the study drugs

Where it is running

• 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
• Uc Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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