MTN will implement a broach spectrum of clinical trials between 2006 and 2013. Currently ongoing or planned MTN trials include:

• MTN-004 - A Phase I study evaluating the safety, acceptability and ease of use of the microbicide candidate VivaGel™ in sexually active, HIV-negative women ages 18 to 24. It is the first and only trial designed to evaluate a candidate microbicide in young sexually active women, a population in whom HIV rates are steadily increasing.
• MTN-001 - The first head-to-head comparison of two different pre-exposure prophylaxis (PrEP) modalities – oral and vaginal gel preparations of tenofovir – looking at differences in drug absorption (systemically and locally) and adherence and acceptability of each approach separately and in combination. Understanding how and why women are willing or able to commit to a particular formulation is vital to the development of safe and effective drug-based prevention strategies.
• MTN-002 - The first trial of a candidate microbicide in pregnant women, which seeks to understand the extent of drug absorption during pregnancy and the degree to which the gel’s active ingredient may be transferred to the fetus. Such information is important because, intended or not, women may become pregnant while participating in microbicide trials, and if microbicides ever become widely available, pregnant women will likely use them.
• The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic – Also known as MTN-003, it is MTN’s flagship trial. VOICE is the first study to compare the safety and efficacy of oral versus topical PrEP for prevention of sexual transmission (looking at oral and vaginal formulations of tenofovir) as well as the first trial to compare the safety and efficacy of two oral PrEP approaches in the same trial.
• MTN-005 – An expanded safety and acceptability study of a nonmedicated vaginal ring in sexually active, HIV-negative women being conducted in collaboration with the International Partnership for Microbicides.
• MTN-015 - A long-term, observational study that seeks to understand the nature of HIV progression and treatment response in HIV-positive women who had been using a topical microbicide or oral antiretrovirals as pre-exposure prophylaxis when they were infected. At the current time, there is little information about the short- and long-term consequences for women who may have been using either type of product at the time of infection.

Also included in MTN’s research portfolio are two ongoing trials that prior to 2006 were led by NIAID’s HIV Prevention Trials Network (HPTN):

• HPTN 035 - a multi-center clinical trial that aims to determine whether the candidate microbicides, BufferGel® and PRO 2000, can prevent the sexual transmission of HIV in 3,100 sexually active HIV-negative women. The trial, which was launched in early 2005, involves six sites in Africa and U.S. site. Results of the trial are due in 2008.
• HPTN 059 is a Phase II (expanded safety) trial that aims to assess the safety and acceptability of an antiretroviral-based candidate microbicide called tenofovir gel. It is the first study evaluating daily use of a gel (non-coitally dependant), an approach to HIV prevention researchers believe may be more acceptable to women than having to apply gel at the time of sex. They anticipate reporting results in early 2008.