The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV
Status:
Completed
Trial end date:
1996-03-01
Target enrollment:
Participant gender:
Summary
To determine the safety and pharmacokinetics of F105 human monoclonal antibody both following
a single dose and during intermittent administration in HIV-infected patients. To determine
specific dose concentrations sufficient to achieve efficacy and avoid toxicity. To determine
the effect of F105 on virologic, immunologic, and serologic parameters.
Early in the course of HIV infection, the primary humoral immune response appears to be
highly strain specific and to be directed at a hypervariable portion of the viral gp120. The
F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown
to neutralize the IIIB, SF2, and MN strains of HIV at concentrations readily achievable in
humans.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)