PITTSBURGH, Sept. 15 – 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.
Project collaborators include Bernard J. Moncla, Ph.D., and Charlene Dezzutti, Ph.D., both of Pitt and MWRI; researchers from the University of Washington; the New York State Institute for Basic Research; Johns Hopkins University; and CONRAD.
About the University of Pittsburgh School of Medicine As one of the nation's leading academic centers for biomedical research, the University of Pittsburgh School of Medicine integrates advanced technology with basic science across a broad range of disciplines in a continuous quest to harness the power of new knowledge and improve the human condition. Driven mainly by the School of Medicine and its affiliates, Pitt has ranked among the top 10 recipients of funding from the National Institutes of Health since 1997 and now ranks fifth in the nation, according to NIH data for 2008 (the most recent year for which the data are final).
Likewise, the School of Medicine is equally committed to advancing the quality and strength of its medical and graduate education programs, for which it is recognized as an innovative leader, and to training highly skilled, compassionate clinicians and creative scientists well-equipped to engage in world-class research. The School of Medicine is the academic partner of UPMC, which has collaborated with the University to raise the standard of medical excellence in Pittsburgh and to position health care as a driving force behind the region's economy. For more information about the School of Medicine, see www.medschool.pitt.edu.
About the University of Pittsburgh School of Pharmacy
Chartered in 1878, the School of Pharmacy is the oldest of the University of Pittsburgh's Schools of the Health Sciences. For over 125 years, the School of Pharmacy has been committed to improving health through excellence, innovation, and leadership in education, research, patient care, and service. Today, the School of Pharmacy is a leader in research, with endeavors ranging from patient care outcomes and human clinical research to research in molecular genetics. The School of Pharmacy is home to four centers: the Center for Pharmacogenetics, the Center for Education and Drug Abuse Research (CEDAR), the Pharmacodynamic Research Center, and the Center for Innovation in Health Care. The School also houses the Cell Imaging Core of the Center for Reproductive Science, a Neuroendocrinology Research Consortium, as well as, considerable chemistry expertise in the Bioanalytical/Proteomics Core and Medicinal Chemistry/Pharmacognosy Group . Collectively, these programs catapulted the School in the year 2000 into the top 10 among schools of pharmacy based on competitive research funding from the National Institutes of Health.