The development of safe and effective prevention strategies against HIV infection is a critical component of the HIV research agenda and, in recent years, the University of Pittsburgh School of Medicine has emerged as a global leader in microbicide development. Ongoing microbicide research is based both in Pittsburgh and at international sites in Africa and India.
A microbicide is a substance designed to prevent transmission of HIV and other sexually transmitted diseases in men and women. It can come in the form of a gel, cream, suppository, film, sponge or ring that releases an active ingredient over time.
The Microbicide Trials Network (MTN) is led by Dr. Sharon Hillier and headquartered at Magee-Womens Research Institute & Foundation in Pittsburgh. The MTN is funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health specifically to conduct clinical trials to evaluate the safety and effectiveness of topical microbicides. Several microbicides are being tested in clinical trials and the present network includes a total of 17 sites located in seven countries.
The concept for a microbicide-like product was developed more than 15 years ago by reproductive health specialists and advocates who recognized the need for female-controlled HIV prevention methods. Beyond being effective, microbicides for HIV prevention must be safe and easy to use.
Microbicides first undergo rigorous testing in the laboratory before testing in humans can occur. Phase I trials evaluate safety in a small number of people exposed to study products for brief periods such as one to two weeks. If those study results suggest the product is safe, investigation then progresses to a Phase II trial. Researchers then track safety of the product over greater periods of time.
Finally, Phase III trials are performed to establish the product’s effectiveness. This type of study is conducted in a large number of participants, and usually involves multiple centers. Studies may be designed to compare one product’s effectiveness with another’s and/or with an inactive agent, or placebo. The data resulting from a Phase III trial are often used by regulatory agencies to determine if a product should be approved for widespread use.
Public health experts estimate microbicides that are even 60 percent effective against HIV could prevent upwards of 2.5 million infections over a three-year period. More research is focusing on the development of rectal microbicides. One current trial involves assessment of rectal safety of microbicide products originally formulated for the vagina, as it is assumed that once vaginal microbicides are licensed they will also be used in the rectum. In addition, a team lead by Dr. Ian McGowan are developing microbicide products formulated specifically for rectal use.
For information about microbicides, the following websites offer a variety of views and news including research and advocacy efforts. They are: http://www.mtnstopshiv.org/; http://www.ipm-microbicides.org/; http://www.global-campaign.org/; and http://www.microbicide.org/.
Persons interested in participating in upcoming local microbicide research studies at the University of Pittsburgh are encouraged to call Anne Davis at 412-641-3381 .