Modulation in vitro of immune parameters in homosexual males with the preclinical complex of symptoms related to acquired immune deficiency syndrome by azimexon

In search of potential therapeutic agents for the acquired immunodeficiency syndrome (AIDS) among homosexual males, we studied in vitro the immunorestorative effect of azimexon in patients with this syndrome. Since a reduction in the ratio between helper inductor and suppressor/cytotoxic T-cell subsets (OKT-4/OKT-8) seems to be the hallmark of the syndrome, we measured azimexon-induced numerical changes in T-cell subsets and correlated them with changes in a simultaneously tested T-cell function as measured by the xenogeneic local graft-versus-host reaction (GVHR). Following incubation of peripheral blood mononuclear cells from 10 homosexual subjects with 10 μg/ml of azimexon at 37°C for 1 h, the median number of T cells defined by the OKT-8 phenotype declined from 0.6 × 10³ to 0.33 × 10³/mm³ (p < 0.02), resulting in an increase in the OKT-4/OKT-8 ratio from 0.65 to 1.37 (p < 0.01). There were no numerical changes in T cells defined by OKT-3 and OKT-4 phenotypes. Similar decreases in OKT-8-defined T cell occurred among eight heterosexual controls. The restoration of the OKT-4/OKT-8 ratio among the homosexual subjects was associated with a significant improvement in their T-cell function. Thus, the median volume of the local GVHR increased from 38.2 to 63.5 mm³ (p < 0.02). Parallel changes in OKT-4/OKT-8 ratio and changes in local GVHR following incubation with azimexon were observed. These results suggest that azimexon may be an important immunorestorative agent. Clinical trials with this agent in patients with AIDS or its preclinical complex of symptoms seem warranted.