About the Microbicide Trials Network
• The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases (NIAID), with co-funding from the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), all components of the U.S. National Institutes of Health.

• The MTN brings together international investigators and community and industry partners who are devoted to reducing the sexual transmission of HIV through the development and evaluation of products applied topically or administered orally, working within a unique infrastructure specifically designed to facilitate the research required to support licensure for these products for widespread use.

• Based at the University of Pittsburgh and Magee-Womens Research Institute in Pittsburgh, Pennsylvania, USA, MTN’s core operations are supported by a network laboratory at the University of Pittsburgh, a statistical and data management center housed within the Statistical Center for HIV/AIDS Research & Prevention at the Fred Hutchinson Cancer Research Center, and Family Health International, a global organization with expertise conducting clinical protocols.

• The MTN comprises 18 clinical research sites in seven countries: Malawi, South Africa, Uganda, Zambia, Zimbabwe, India and the United States (New York City; Cleveland, Ohio; Pittsburgh; Philadelphia, Pennsylvania; and Birmingham, Alabama.) MTN also conducts studies at two additional sites in Tampa, Florida and San Juan, Puerto Rico in collaboration with the NICHD’s Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN).

• MTN’s research portfolio is designed to face the global urgency of the HIV/AIDS epidemic head-on. Between 2006 and 2013, it will implement a broad spectrum of clinical trials in Africa, India and the United States, including studies considered among the most critically important for advancing the field of HIV prevention.

• The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic – is the only trial evaluating in parallel two promising HIV prevention approaches for their safety and effectiveness in preventing HIV infection in women. One approach involves daily use of the antiretroviral (ARV)-based vaginal microbicide tenofovir topical gel, and the second approach, called pre-exposure prophylaxis (PrEP), involves taking an ARV pill every day. VOICE is also the first effectiveness trial of a microbicide that women use every day instead of at the time of sexual intercourse, and one of the first trials of a microbicide with specific action against HIV.

• Microbicides, products designed to prevent sexual transmission of HIV, are being developed predominantly for sexually active women of reproductive age, yet no study has ever involved pregnant women to understand if using microbicides during pregnancy is safe. The MTN is conducting the first clinical trial of a candidate vaginal microbicide in pregnant women, looking at pregnancy’s effect on how the body absorbs the active drug in tenofovir gel and whether the drug can be transferred to the fetus.

• MTN is conducting the first long-term observational study of women who become infected with HIV while participating in a trial of either a topical microbicide or oral PrEP. Such a study is essential for better understanding the impact these agents may have on HIV progression and response to therapy over time and the potential for and control of drug resistance in HIV prevention trials of ARVs and ARV-based microbicides.

• As part of MTN’s scientific agenda, researchers plan to conduct Phase I rectal safety and drug absorption studies of the vaginal formulation of tenofovir gel. Preclinical evaluation of candidate microbicides for rectal safety and efficacy is also being conducted in MTN’s Network Laboratory using a unique tissue explant model.

About Microbicides
• Microbicides are substances designed to prevent or reduce the sexual transmission of HIV when applied topically on the inside of the vagina or rectum. A microbicide can be formulated in many ways, such as a gel or cream, or as a ring that would release the active ingredient over time. Some microbicides are also being developed for rectal use. Several microbicide products are being tested in clinical trials, including trials conducted by the MTN, although none is currently approved or available for use.

• If proven effective, microbicides could be an inexpensive and readily available approach for women who cannot rely on male condom usage or abstinence as methods for protecting themselves from HIV.

Why Microbicides Are Needed
• Between 70 and 90 percent of all HIV infections in women are due to heterosexual intercourse. Moreover, women are twice as likely as their male partners to acquire HIV during sex, due in part to biological factors that make women more vulnerable.

• Particularly in developing countries, educational efforts promoting abstinence, monogamy and condoms have not been completely effective.

• According to statistics from UNAIDS and the U.S. Centers for Disease Control and Prevention, nearly half, or 46 percent, of the 33.2 million people living with HIV/AIDS worldwide are women. In sub-Saharan Africa, women account for 61 percent of all infected adults.

• Young women are especially vulnerable, especially in sub-Saharan Africa, where it has been estimated that women aged 15 to 24 with HIV represent 76 percent of the total cases in that age group, outnumbering their male peers by three to one.

For more information about the Microbicide Trials Network go to www.mtnstopshiv.org.
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5/30/08