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PROJECT The main ingredient in the candidate microbicide PC-815 is MIV-150 a non-nucleoside reverse transcriptase inhibitor (NNRTI), which binds to reverse transcriptase enzymes that in turn prevents the cell from producing new virus). MIV-150 was originally being developed in a joint venture by Medivir AB (Huddinge, Sweden) and Chiron Corporation (Emeryville, CA) (Medivir/Chiron) as an anti-HIV therapeutic. In nonclinical tests conducted by Medivir/Chiron, MIV-150 has shown significantly increased activity against HIV-1 primary isolates, mutants, and strains of HIV-1 resistant to other anti-HIV drugs. An extensive pharmacology and toxicology profile prove that MIV-150 is nontoxic in vitro and in vivo but demonstrated poor bioavailability when taken orally. However, this property makes it ideal for use in a microbicide because it diminishes the chances that MIV-150 will cause systemic side effects. Pharmacological testing conducted in vitro has indicated that PC-815’s activity against HIV is significantly higher than the activity of Carraguard alone. PC-815 is currently formulated as a gel combining MIV-150 with Carraguard. Quality tests have shown that PC-815’s chemical components are stable and do not interact, causing degradation. Impurity and microbiological analysis has verified the absence of any form of contamination within the formulation, and a study has proven the effectiveness of the formulation’s preservative. Currently, two-year stability studies are in progress. Toxicological testing has established that PC-815 is not toxic to vaginal cells in vitro and vaginal epithelial cells in rabbits. Additional testing is under way, which will indicate its effect on the vaginal epithelia of rabbits and rats following longer duration of exposure and increased frequency of dosing. Council researchers are also exploring MIV-150 delivered in a vaginal ring. * Carraguard® is the Population Council's U.S. trademark for pharmaceutical preparations, namely microbicides, for use in preventing infection. Location New York, New York Duration 2002–present Population Council researcher Non-Council collaborators Ethox International, Sterilization Technical Services Life Sciences Division National Food Laboratory TherImmune (Gene Logic) Toxikon Donors Swedish International Development Cooperation Agency Swedish Ministry of Foreign Affairs US Agency for International Development
Publications/Resources
2007 Related Projects Contact: microbicide@popcouncil.org
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