Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults

Phase 2 Terminated 210 enrolled ViiV Healthcare GlaxoSmithKline · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.

Timeline

Start: 2015-05-12
Primary completion: 2016-05-26
Completion: 2017-08-21

Outcome

Outcome not reported

Stopped: “The trial ended early due to GI intolerability and treatment-emergent resistance.”

Publications

Morales-Ramirez J, Bogner JR, Molina JM, Lombaard J, Dicker IB, Stock DA, DeGrosky M, Gartland M, Pene Dumitrescu T, Min S, Llamoso C, Joshi SR, Lataillade M. Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial. PLoS One. 2018 Oct 23;13(10):e0205368. doi: 10.1371/journal.pone.0205368. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BMS-955176	Other / unclassified	60 mg	Oral
Subject	BMS-955176	Other / unclassified	120 mg	Oral
Subject	BMS-955176	Other / unclassified	180 mg	Oral
Comparator	Efavirenz	Other / unclassified	600 mg	—
Background	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Background	emtricitabine	Other / unclassified	200 mg	Oral