Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist
INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not
currently on a HAART regimen and have not received any antiretroviral agents for 3 months
prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered
orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead
electrocardiograms, physical examinations and virologic assessments, including viral load,
viral tropism and CD4+ cell count determinations will be performed at the Screening visit and
at regularly scheduled visits throughout the study. A blood sample will also be obtained and
stored to potentially determine the genotype of the CCR5 receptor.
The primary objectives are:
1. Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered
orally, once daily, as monotherapy for 14 days;
2. Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered
orally, once daily, as monotherapy for 14 days;
3. Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when
administered orally, once daily, as monotherapy for 14 days