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

Phase 2 Terminated 297 enrolled Bristol-Myers Squibb

RandomizedParallel-groupQuadruple-blindTreatment

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 Immunodeficiency Virus 1 (HIV-1) infected subjects

Timeline

Start: 2011-02
Primary completion: 2013-03
Completion: 2014-07

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CENSAVUDINE	Small molecule	100 mg	Oral
Subject	CENSAVUDINE	Small molecule	200 mg	Oral
Subject	CENSAVUDINE	Small molecule	400 mg	Oral
Subject	Tenofovir	Small molecule	300 mg	Oral
Background	Efavirenz	Other / unclassified	600 mg	Oral
Background	Lamivudine	Other / unclassified	300 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications