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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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


Condition Intervention Phase
HIV Infections
 Drug: HIV Integrase Inhibitor (BMS-707035)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-707035 in HIV-1 Infected Subjects

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome 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

Enrollment: 0
Study Start Date: February 2007
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00397566     History of Changes
Other Study ID Numbers: AI441-008
Study First Received: November 8, 2006
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council
Mexico: Secretaría de Salud de México (Mexico's Ministry of Health)

Keywords provided by Bristol-Myers Squibb:
HIV
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013