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

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ClinicalTrials.gov Identifier: NCT00397566
Recruitment Status : Withdrawn
First Posted : November 9, 2006
Last Update Posted : April 27, 2012
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief 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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: HIV Integrase Inhibitor (BMS-707035) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




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

Secondary Outcome Measures :
  1. Safety and tolerability with 10 days of dosing
  2. Effect on QTc intervals
  3. Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte
  4. Pharmacokinetics of multiple doses of BMS-707035 in HIV-1 infected subjects
  5. Assess relationship of EC90 and exposures of BMS-707035 to the magnitude of change in viral loads
  6. Assess plasma protein binding and intracellular concentration in PBMC for BMS-707035


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Additional Information:
ClinicalTrials.gov Identifier: NCT00397566     History of Changes
Other Study ID Numbers: AI441-008
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Bristol-Myers Squibb:
HIV
Treatment Experienced

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