The goal of this proposal is to develop a safe, effective, acceptable, and affordable, dendrimer-based vaginal microbicide to reduce the risk of transmission of viral sexually transmitted infections. Dendrimers are monodisperse macromolecules with highly-branched, tree-like, single molecule, polymeric structures with a broad spectrum of antiviral actions. Fifty dendrimers will be screened, five characterized in more detail, and two formulated and evaluated for preclinical efficacy and safety in animal models genital herpes. HIV and HBV anti-viral activities will be evaluated outside of the SBIR. The ultimate goal is to select and develop a single dendrimer formulated for commercial use. Antimicrobial activities, toxicity, mechanisms of action, spermicidal activity, and in vitro antiviral activity will be systematically evaluated in anticipation of an IND submission for phase I clinical trials in humans.
