The MTN is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases, with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.
The MTN brings together international investigators and community and industry partners whose work is focused on the rigorous evaluation of promising microbicides – products applied inside the vagina or rectum to prevent the sexual transmission of HIV – and of dual-purpose products for preventing both HIV and unintended pregnancy.
MTN studies are designed specifically to support the potential licensure and regulatory approval of these products for particularly vulnerable populations: adolescent girls and young women; pregnant and breastfeeding women, gay men and other men who have sex with men and transgender women. More than 25 clinical research sites on four continents have partnered with the MTN in the conduct of its clinical trials. Collectively, more than 11,000 research participants have taken part in MTN studies.
Unlike condoms, microbicide products are controlled by the user, not a sexual partner. And unlike other biomedical approaches that rely on systemic delivery of anti-HIV drugs, microbicides deliver drugs directly to the site of potential infection.
Microbicide products could offer an additional option for people who, for various reasons, may not want to or cannot access proven methods, such as condoms or daily use of Truvada as PrEP to reduce their risk of HIV.
Several microbicide products are in various stages of clinical evaluation, with the monthly dapivirine ring the furthest along and possibly the first product to receive regulatory approval. Other vaginal formulations being evaluated include three-month rings, fast-dissolving films and tablet-like inserts. Rectal microbicide formulations currently being developed and evaluated include gels, douches and fast-dissolving suppository-like rectal inserts
The MTN is led by Sharon Hillier, Ph.D., of the University of Pittsburgh and Magee-Womens Research Institute, who serves as principal investigator. The MTN is comprised of a Leadership and Operations Center; a Laboratory Center with expertise in immunology, virology and microbiology; and a Statistical and Data Management Center. Because effectiveness of a product is also dependent on use, behavioral science is integrated throughout MTN’s unique research portfolio.