Status:
TERMINATED
Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT01489046
Start Date
February 1 2011
End Date
July 1 2014
Last Update
April 15 2016
Active Locations (51)
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1
Uc Davis Medical Center
Sacramento, California, United States, 95817
2
Orlando Immunology Center
Orlando, Florida, United States, 32803
3
Triple O Medical Services, P.A.
West Palm Beach, Florida, United States, 33401
4
Aids Research Consortium Of Atlanta
Atlanta, Georgia, United States, 30308