Back to resultsA Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects
Primary Purpose
HIV Infections
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HIV Integrase Inhibitor (BMS-707035)
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Experienced
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00397566
Brief Title
A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
HIV Integrase Inhibitor (BMS-707035)
Primary Outcome Measure Information:
Title
To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.
Secondary Outcome Measure Information:
Title
Safety and tolerability with 10 days of dosing
Title
Effect on QTc intervals
Title
Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte
Title
Pharmacokinetics of multiple doses of BMS-707035 in HIV-1 infected subjects
Title
Assess relationship of EC90 and exposures of BMS-707035 to the magnitude of change in viral loads
Title
Assess plasma protein binding and intracellular concentration in PBMC for BMS-707035
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects
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