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BMS-955176 multiple-dose study in HIV-1 infected subjects
2012-004124-38Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2012
- Countries
- 1
- Sponsor
- Bristol Myers Squibb
- Modality
- Small Molecules
- Drugs
- BMS-955176
- Conditions
- Human immunodeficiency virus infection type 1
01
Overview
Phase 2, randomised, double-blind trial of BMS-955176 in Human immunodeficiency virus infection type 1 (4 arms), sponsored by Bristol Myers Squibb. Primary endpoint: Change in plasma HIV-1 RNA from baseline on Day 11. Started Dec 2012; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
BMS-955176 double-blind treatment
Randomized double-blind BMS-955176 multiple-dose arm.
Placebo double-blind control
Randomized double-blind placebo control arm.
BMS-955176 plus atazanavir open-label
Open-label cohort assessing coadministration with atazanavir.
BMS-955176 plus atazanavir plus ritonavir open-label
Open-label cohort assessing coadministration with atazanavir and ritonavir.
03
Who it enrols
Adults with HIV-1 infection were eligible after providing signed written informed consent. Detailed inclusion and exclusion criteria were not fully provided beyond diagnosis and target disease-related exclusions.
04
Endpoints
Primary
Change in plasma HIV-1 RNA from baseline on Day 11
Secondary
Safety and tolerability
Pharmacokinetics
Pharmacodynamics
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