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

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: HIV Integrase Inhibitor (BMS-707035)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.