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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00397566
First received: November 8, 2006
Last updated: April 26, 2012
Last verified: April 2012

November 8, 2006
April 26, 2012
February 2007
Not Provided
To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.
Same as current
Complete list of historical versions of study NCT00397566 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects
Randomized, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-707035 in HIV-1 Infected Subjects

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: HIV Integrase Inhibitor (BMS-707035)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2007
Not Provided

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00397566
AI441-008
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP