Overview

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

Status:
Withdrawn
Trial end date:
2007-02-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
BMS-707035
HIV Integrase Inhibitors
Integrase Inhibitors
Criteria
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