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PROJECT
Nonclinical Laboratory Studies:
PC-815
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
Council researchers' names appear in boldface type.
2007
Fernández-Romero,
José A., Mitchell Thorn, Stuart G. Turville, Kanani Titchen,
Kristin M. Sudol, Jifan Li, Todd Miller, Melissa
Robbiani, Robin A. Maguire, Robert
W. Buckheit Jr., Tracy L. Hartman, and David M. Phillips.
"Carrageenan/MIV-150
(PC-815), a combination microbicide," Sexually Transmitted Diseases
34(1): 9–14. (abstract)
Related Projects
Contact: microbicide@popcouncil.org
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HIV prevention news: PRO 2000, a candidate microbicide developed by Indevus Pharmaceuticals, Inc., and tested in a clinical trial in six countries on two continents, was found to be safe and to have reduced the risk of HIV infection by 30 percent. While not statistically significant, this finding was welcomed by the HIV-prevention field as an optimistic sign for future success. (more) The Lancet’s 6 December issue features results from the Phase 3 trial of Carraguard®. (Trial results were announced previously by the Population Council in February 2008.) (more) For fact sheets and other resources about the Carraguard trial, click here Presentations at the Microbicides 2008 conference in New Delhi by Council researchers are available. (more) "Benefits of the Population Council's microbicides program and Phase 3 Carraguard trial" (2008) (PDFs: A4 and letter)
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"Carrageenan/MIV-150 |