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NCT00397566 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Randomized, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-707035 in HIV-1 Infected Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00397566
Other study ID # AI441-008
Secondary ID
Status Withdrawn
Phase Phase 2
First received November 8, 2006
Last updated April 26, 2012
Start date February 2007
Est. completion date February 2007

Study information
Verified date April 2012
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilMexico: Secretaría de Salud de México (Mexico's Ministry of Health)
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• HIV Integrase Inhibitor (BMS-707035)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.
Secondary Safety and tolerability with 10 days of dosing
Secondary Effect on QTc intervals
Secondary Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte
Secondary Pharmacokinetics of multiple doses of BMS-707035 in HIV-1 infected subjects
Secondary Assess relationship of EC90 and exposures of BMS-707035 to the magnitude of change in viral loads
Secondary Assess plasma protein binding and intracellular concentration in PBMC for BMS-707035
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