Study to find at least one dose of BMS-955176 that will be safe, effective and tolerable in HIV-1 infected treatment naive adults

Phase 1

• Conditions: HIV; MedDRA version: 18.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-005487-26-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-20
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- Men and non-pregnant women, at least 18 years of age
- Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week of an antiretroviral drug
Plasma HIV-1 RNA > or = to 1000 copies/mL
- CD4 T-cell count > 200 cells/mm3

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 278
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

- Resistance or partial resistance to any study drug determined by tests at Screening
- Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors, (Please see protocol for further information on these exclusionary mutations)
- Chronic HBV/HCV
- Blood tests that inidcate normal liver function (see protocol)
- Hemoglobin < 8.0 g/dL and Platelets < 50,000 cells/mm3

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified