A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects

Bristol-Myers Squibb

Overview

The purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of BMS-707035 in subjects infected with HIV-1

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

HIV Infections

Interventions

HIV Integrase Inhibitor (BMS-707035)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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