Monoclonal antibody hNM01 in HIV-infected patients: a phase I study

hNM01 is a humanized monoclonal antibody that binds to the V 3 region of the HIV-1 envelope protein gp120. This binding leads to the activation of complement and the disruption of the viral envelope. The aim of this study was to investigate the clinical responses of the individuals when treated with the humanized antibody NMO1. In this phase I study, four HIV-1 infected patients with CD4 counts between 50 and 500 cells/μl received a total of four doses of hNM01 in an intrapatient dose escalation fashion: day 1–0.2 mg/kg, day 15–1 mg/kg, day 29–5 mg/kg, and day 43–5 mg/kg. Patients were required to have virus that reacted to hNM01 by a virion capture assay and to have a viral load ≥15,000 copies/mL. The antibody was well-tolerated; no significant adverse events were observed even at the highest dose tolerated. None of the patient developed either human anti-hNM01 (anti-idiotype) or human anti-rat antibodies. The mean elimination half-life was 153 h (6.4 days). During hNMO1 therapy effects were observed on CD4 cell counts and plasma viral loads and further dose finding trials are necessary to better determine the therapeutic activity of hNM01 in HIV-infected individuals.