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PROJECT
Clinical Studies: PC-815  

The next-generation microbicide PC-815 is a combination of the Population Council’s microbicide candidate, Carraguard®, and the non-nucleoside reverse transcriptase inhibitor MIV-150. This dual formulation provides PC-815 with two different ways to block HIV, enhancing its ability to prevent infections. In a joint venture, Medivir AB and the Chiron Corporation originally developed MIV-150 as an oral treatment drug, but poor absorption made it inappropriate for oral use. This same characteristic, however, makes MIV-150 an ideal candidate for a topical microbicide.

An applicator especially designed by the Council for testing candidate microbicides will be used in the PC-815 safety study

An applicator especially designed by the Council for testing candidate microbicides will be used in PC-815 studies.

In 2003, Medivir/Chiron granted the Population Council exclusive licensing rights to MIV-150. Extensive toxicology studies have demonstrated that MIV-150 is safe for human use, and laboratory studies have shown MIV-150 to be effective at extremely low concentrations. Carraguard has been studied extensively in the lab and in humans, and has been shown to be safe for vaginal use. Therefore the combination of MIV-150 and Carraguard in PC-815 is expected to be safe as well. Future studies are being planned.


Location

Santo Domingo, Dominican Republic; Soshanguve, South Africa

Duration

2003ongoing

Population Council researchers

Robin Maguire, Sumen Govender

Non-Council collaborators

Vivien Brache (Asociación Dominicana Pro-Bienestar de la Familia)

Khatija Ahmed (Setshaba Research Center, University of Limpopo/Medunsa campus)

Donors

Swedish International Development Agency

Swedish Ministry of Foreign Affairs

US Agency for International Development
 

Publications/Resources
Council researchers' names appear in boldface type. 

2007
"Tests suggest new microbicide will have improved efficacy," Population Briefs 13(2). (full text)

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)


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This page updated
18 February 2008


   

What's New

Council selects Louise Pedneault clinical director, microbicides, HIV and AIDS program (more)

Presentations by Council researchers at the Microbicides 2008 conference in New Delhi are now available. (more)

"Disappointment in trials another lesson," 26 February 2008 op-ed from The Star, South Africa (posted with permission) (PDF)

The results of the Phase 3 Carraguard® trial have been announced. (more)

For fact sheets and other resources about the Carraguard trial, click here.

"Benefits of the Population Council's microbicides program and Phase 3 Carraguard trial" (2008) (PDFs: A4 and letter)

"Day of dialogue—Insights and evidence from product introduction: Lessons for microbicides" (2007) (PDF)

"Ethics in clinical trials: Population Council's microbicides program," describes the Council's efforts to ensure microbicide research is ethical and transparent. (PDF)

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Publications/Resources

"Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing" (2005) (abstract)

The Council has a fact sheet for those seeking additional information about the Carraguard trials: "The Population Council, HIV and AIDS, and microbicides" (full text) (PDF)

"Developing and testing a gel to prevent HIV transmission" (2005) (full text)

More