HIV Infections
Conditions
Keywords
HIV, Treatment Experienced
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
Interventions
DRUGHIV Integrase Inhibitor (BMS-707035)
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect on QTc intervals | — |
| Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte | — |
| Safety and tolerability with 10 days of dosing | — |
| 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 | — |
| Pharmacokinetics of multiple doses of BMS-707035 in HIV-1 infected subjects | — |
Outcome results
None listed