Pittsburgh, June 30 – The University of Pittsburgh-affiliated Magee-Womens Research Institute is one of six institutions selected to lead HIV/AIDS prevention and treatment efforts by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). Estimated at $285 million in funding for the first year, these leadership group awards represent the first step of a two-part restructuring process of the NIAID's clinical trials networks.
Sharon L. Hillier, Ph.D., professor of obstetrics, gynecology and reproductive sciences and of molecular genetics and biochemistry at the University of Pittsburgh School of Medicine, is principal investigator for the Pittsburgh consortium, which has been designated to lead the Microbicide Trials Network (MTN). The mission of the MTN is to develop new drugs and drug delivery systems to prevent HIV and its spread.
"The leading method of transmission for HIV/AIDS infection today is heterosexual intercourse," said Dr. Hillier, who also is a senior investigator at the Magee-Womens Research Institute. "And in many parts of the world, a woman's single biggest risk factor for the acquisition of HIV is being married. Currently, women have no way to protect themselves except condoms, and women do not control condom use."
Dr. Hillier's group is involved in evaluating drugs for the prevention of sexually transmitted infections such as HIV. Clinical trials have been designed to support the licensing of new agents for the prevention of HIV that could be used by women at risk of infection both in the U.S. and internationally. NIAID's decision to fund the MTN reflects a growing recognition that novel approaches to prevention will be needed to slow the epidemic of AIDS.
"Pittsburgh proved its scientific worth more than 50 years ago when the development of the Salk vaccine signaled an end to the scourge of polio," said Arthur S. Levine, M.D., senior vice chancellor, health sciences, and dean of the University of Pittsburgh School of Medicine. "Perhaps soon we can point to efforts here that will lead to a similar end to the deadly spread of HIV/AIDS."
More than 4 million new HIV infections yearly, the majority of which are sexually transmitted, make the prevention of sexual transmission of HIV a top public health priority. The Pittsburgh-based MTN will focus on the identification and development of topically applied drugs called microbicides in a form that is acceptable both for the women who will use them and for their partners.
"The global HIV epidemic is spreading among women and young girls at an alarming rate," said Dr. Nicholas Hellmann, acting director of HIV, TB and reproductive health programs at the Bill & Melinda Gates Foundation. "By accelerating the development of new prevention methods such as microbicides, we have an opportunity to save millions of lives."
Dr. Hillier explained that with microbicides, drug agents proven to have activity against HIV can be applied directly to areas of the body where the infection takes place.
"While the development and testing of topical microbicides for prevention of HIV might seem to be straightforward, these products need careful evaluation because they will be used repeatedly with each act of intercourse over many years," said Dr. Hillier. "This requires a subtle balance between toxicity and effectiveness, ease of use and, ultimately, cost."
Several large clinical trials are currently ongoing to test the safety and efficacy of a number of microbicidal preparations. The MTN designation will continue this international effort with support for these ongoing clinical trials in several countries including Africa and India. Locations of sites for new clinical trials, along with finalized budgets, will be released when the second phase of the funding plan is available from NIAID.
"We are pleased and proud to receive this recognition from the National Institutes of Health," said James M. Roberts, M.D., director of the Magee-Womens Research Institute. "To be able to bring a project of this magnitude to Pittsburgh is consistent with our commitment to improving the health of women and their infants around the world."
In addition to Dr. Hillier, University of Pittsburgh faculty members involved in the MTN project include John W. Mellors, M.D., professor of medicine, and chief of the division of infectious diseases and director of the HIV/AIDS program at the University of Pittsburgh Medical Center; Charlene Dezzutti, Ph.D., associate professor of obstetrics, gynecology and reproductive sciences and molecular genetics and biochemistry; Bernard J. Moncla, Ph.D., research associate professor, obstetrics, gynecology and reproductive sciences; and Lisa Cencia Rohan, Ph.D., assistant professor, pharmaceutical sciences and obstetrics, gynecology and reproductive sciences. Research partners for the MTN also come from 20 other leading universities.
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