Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered
via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to
study drug, all patients will receive an optimized background regimen (OBR), which is a
standard-of-care regimen selected by the investigator prior to randomization that is
comprised of 2-4 antiretroviral agents. These agents must have been approved by the local
regulatory agency or be available through expanded-access programs for treatment of human
immunodeficiency virus (HIV).