A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects
Status and phase
Withdrawn
Phase 2
Conditions
HIV Infections
Treatments
Drug: HIV Integrase Inhibitor (BMS-707035)
Details and patient eligibility
About
The purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of BMS-707035 in subjects infected with HIV-1
Sex
All
Ages
18 to 60 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Double Blind
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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