Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy
Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
Summary
This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in
HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy.
Subjects will be randomly assigned to receive a single intravenous (IV) infusion of one of
four dose levels of CCR5mAb004 or matching placebo. A minimum of 10 subjects will be
randomized to each cohort at a ratio of 4:1 (active:placebo). A minimum of 40 and maximum of
60 subjects will be enrolled. This study will be conducted at up to 10 sites in the United
States.
Subjects in each cohort will be followed for 56 days after study agent administration. The
safety, tolerability, and immunogenicity of CCR5mAb004 will be evaluated based on physical
examination, adverse event (AE) reporting, and clinical laboratory tests. Blood will be
collected at specified times for the determination of CCR5mAb004 serum concentrations, HIV-1
RNA levels, and CD4+ and CD8+ cell counts. If CD4+ cell counts are less than 200 during the
study period, the subject should be offered standard-of-care per HIV treatment guidelines
that may include the initiation of appropriate anti-retroviral therapy (AVR). CCR5mAb004
pharmacokinetic (PK) and pharmacodynamics (PD) will be measured over the 56-day study period.
Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and
Day 56.