Development of immunomodulators for treatment of HIV infection.

Although considerable attention has been devoted to development of antiviral drugs for therapy of HIV infection, relatively little priority has been directed to correction of the progressive immunologic defect that develops in these patients. We described the development of the therapeutic effect of an immunosupportive biological agent (IMREG-1) derived from human leukocytes. Specifically, IMREG-1 reduced the risk of progression from advanced AIDS-related complex (ARC) based on a randomized double-blinded control trial over a six month period of the laboratory and clinical parameters predictive of a high risk of progression from ARC to AIDS. The comparative value of CD4+ cell numbers, anergy to recall antigens and symptomatology in assessing risk of progression were also examined.