A phase I study of the pharmacokinetics and safety of passive immunotherapy with caprine anti-HIV antibodies, PEHRG214, in HIV-1-infected individuals

Abstract

Purpose: To establish the pharmacokinetics and safety of single-dose polyclonal caprine anti-HIV antibodies (PEHRG214) in HIV-1-infected individuals. Design: A phase 1, open-label, nonrandomized, dose-escalating study. Method: HIV-1-infected patients with CD4+ T-cell counts of ≤200 cells/μL and plasma HIV viral load (VL) of ≥5,000 copies/mL received a single intravenous dose of HRG. Dosing began at 6,000 U/kg HRG with proposed step-wise escalation to 96,000 U/kg. Results: Eleven males were enrolled; median CD4+ T-cell count and VL were 96 cells/μL and 126,200 copies/mL, respectively. HRG exhibited linear pharmacokinetics across the dosing range studied. The mean terminal elimination half-lif..