Ongoing and Planned Trials

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), part of the U.S. National Institutes of Health (NIH). 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. 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. Following are brief descriptions of ongoing and planned trials: HPTN 035 – A multi-center clinical trial that aims to determine the safety and effectiveness of two different candidate microbicides, BufferGel® and PRO 2000, in 3,100 sexually active HIV-negative women at seven sites in Malawi, South Africa, Zambia, Zimbabwe and the United States. Enrollment of the trial has been completed and results are due in 2009. MTN-001 – The first direct comparison of the tablet and vaginal gel preparations of the antiretroviral (ARV) drug tenofovir – looking at differences in drug absorption (systemically and locally) and adherence and acceptability of each approach separately and in combination. The Phase II trial, which is expected to begin June 2008, involves 144 sexually active, HIV-negative women at sites in Uganda, South Africa and the United States. MTN-002 – The first study of a candidate topical microbicide in pregnant women, this Phase I study seeks to understand if and to what extent pregnancy affects how the body absorbs the active drug in the ARV-based candidate microbicide tenofovir gel and whether the drug can be transferred to the fetus. The study involves 16 pregnant women who receive a single dose of tenofovir gel prior to scheduled caesarean delivery. The study begins June 2008 at the University of Pittsburgh. MTN-003 – The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic – is a major HIV prevention trial that will evaluate the safety and effectiveness of two different approaches for preventing sexual transmission of HIV in women as well as determine which of these routines women are more apt to follow: taking an antiretroviral (ARV) pill once a day, an approach known as pre-exposure prophylaxis (PrEP), or applying a vaginal microbicide gel on a daily basis. Specifically, the Phase IIb trial will evaluate two ARV pills – tenofovir (Viread®) and Truvada® – and the ARV-based candidate microbicide tenofovir gel. Researchers will enroll 4,200 sexually active HIV-negative women at sites in Africa beginning early 2009. MTN-004 – A safety and acceptability study looking at the candidate microbicide VivaGel™ (SPL7013 Gel) in 40 sexually active, HIV-negative women ages 18 to 24. The study began enrolling women in Tampa, Florida, U.S.A., and San Juan, Puerto Rico, in August of 2007, in collaboration with the Adolescent Medicine Trials Network for HIV/AIDS Interventions of the U.S. National Institute of Child Health and Human Development. MTN-005 – An expanded safety and acceptability study of a nonmedicated vaginal ring made of a silicone elastomer in 252 sexually active, HIV-negative women. The study will be conducted at three sites– one in India and two in the United States, in collaboration with the International Partnership for Microbicides. MTN-007 – A Phase I safety trial in development that seeks to evaluate tenofovir topical gel in both men and women who practice receptive anal intercourse. The study will be conducted at U.S. sites. MTN-015 – A long-term, observational study that seeks to understand the nature of HIV progression and treatment response in HIV-positive women who become infected incidental to their participation in a HIV prevention trial of either a topical microbicide or oral PrEP. The study will help better understand the impact of these agents on the natural history and clinical course of HIV. Importantly, MTN-015 will help address theoretical questions about HIV drug resistance. MTN-016 – A first-of-its-kind registry of women who become pregnant while participating in an HIV prevention trial of either a microbicide or an oral antiretroviral drug or who participated in a trial involving pregnant women, such as MTN-002. The registry, which is in development, will help determine the effects, if any, that early exposure to these products may have on fetal and/or neonatal development. Based at the University of Pittsburgh and Magee-Womens Research Institute in Pittsburgh, Pennsylvania, 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 in Seattle, Washington, and Family Health International, a global organization with expertise conducting clinical protocols. MTN receives its funding from three NIH institutes: NIAID, the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Among the groups developing and evaluating microbicides for HIV prevention globally, the MTN is the only one funded by NIH. MTN’s principal investigator is Sharon Hillier, Ph.D. For more information about the Microbicide Trials Network go to www.mtnstopshiv.org. # # # 5/29/08