This clinical research study will assess the effectiveness (how well it works), safety, tolerability (how well the body stands the drug) and blood levels of combined doses of BMS-663068, Raltegravir and Tenofovir.
- Conditions
- Human immunodeficiency virus type 1 (HIV-1)-infectionMedDRA version: 14.0Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-000437-36-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
Key inclusion criteria:
Plasma HIV-1 RNA ? 1000 copies/ml
Men and women
At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher)
Antiretroviral treatment-experienced as defined in this protocol
Susceptibility to study drugs by genotype/phenotype/PhenoSense® Entry (AI)
CD4+ T-cell count > 50 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 250
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Key exclusion criteria:
Chronic HBV/HCV infection
Contraindications to any of study drugs
History of resistance to any component of the study regimen (TDF, ATV, RAL)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method