Researchers to develop vaginal microbicide gels to reduce HIV risk

With the support of an $11.8 million, five-year federal grant, researchers at the University of Pittsburgh and their collaborators are developing a quick-dissolving vaginal film containing a powerful drug that reduces the risk of HIV infection, and they plan to begin testing it locally within a year.

A small film, like those used to deliver breath fresheners, could have several advantages over vaginal microbicide gels that are already being tested overseas, said Sharon Hillier, Ph.D., professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine, senior investigator at Magee-Womens Research Institute (MWRI), and co-principal investigator of the new project, which is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

"Multiple films could be packaged in discrete cartridges without the need for refrigeration, making them portable and easier to store and distribute, and therefore probably cheaper than a gel," she noted. "And, because they aren't likely to be as messy as a gel, women might be willing to use them routinely, perhaps on a daily basis."

Led by co-principal investigator Lisa Cencia Rohan, Ph.D., associate professor, University of Pittsburgh School of Pharmacy, and MWRI associate investigator, the researchers will first develop a film version of the anti-retroviral drug tenofovir and establish the necessary processes to make it on a large scale for human use. Tenofovir in its pill form is used as an HIV treatment, and South African researchers recently showed that a gel formulation of the drug cut the risk of HIV infection by more than half among women who were most conscientious about applying it before and after intercourse; the gel reduced the infection risk by 39 percent among women who were less vigilant.

The film would provide an alternative dosage form that preclinical testing suggests can release the drug faster and more efficiently than the gel version.

"An effective microbicide strategy should include different forms of the product," Dr. Rohan said. "Women will have preferences, and having options to meet those needs will lead to greater use and therefore better protection from infection."

In addition to tenofovir, the researchers will develop and test a second film containing another anti-HIV agent that has yet to be determined.