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

Status:	Terminated
Conditions:	HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	February 2011
End Date:	July 2014

A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose

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

Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators)
through Week 48.

Inclusion Criteria:

- 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 Criteria:

- 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

We found this trial at

sites

Jacobi Medical Center

1400 Pelham Parkway South
Bronx, New York 10461

(718) 918-5000