A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects
Phase 2
Withdrawn
- Conditions
- HIV Infections
- Registration Number
- NCT00397566
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of BMS-707035 in subjects infected with HIV-1
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- HIV-1-infected subjects with CD4+ lymphocyte count ≥ 200 cells/mm3 and with plasma HIV-1 RNA ≥ 5000 copies/mL who have not been on antiretroviral (ARV) therapy for ≥ 8 weeks or who are naive to ARV, and who are otherwise medically stable as determined by medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. In addition, subjects must have had no prior exposure to the Integrase Inhibitor class of compounds.
- Female subjects must not be nursing, pregnant, or of childbearing potential
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.
- Secondary Outcome Measures
Name Time Method Safety and tolerability with 10 days of dosing Effect on QTc intervals Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte Pharmacokinetics of multiple doses of BMS-707035 in HIV-1 infected subjects Assess relationship of EC90 and exposures of BMS-707035 to the magnitude of change in viral loads Assess plasma protein binding and intracellular concentration in PBMC for BMS-707035