Current and Planned Studies
MTN-003 (VOICE) The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic – was designed to evaluate the safety and effectiveness of two antiretroviral-based approaches for preventing sexual transmission of HIV in women as well as determining which of these women are more likely to follow: applying tenofovir vaginal gel daily or taking an ARV tablet once a day. More info…
MTN-003B (VOICE B)The Bone Mineral Density Sub-study is an observational study in a subset of participants in the VOICE study to explore the effects of oral study products on bone mineral density. More info…
MTN-003C (VOICE C) The Community and Adherence Sub-study aims to identify specific factors within a participant’s household, social environs or broader community that can influence her ability and willingness to follow the daily regimens being tested in VOICE – taking a tablet by mouth or applying a vaginal gel. More info…
MTN-005 An expanded safety and acceptability study of a non-medicated vaginal ring made of a silicone elastomer in sexually active, HIV-negative women. The study is being conducted at three sites – one in India and two in the United States, in collaboration with the Population Council.
MTN-008 A phase I expanded safety and drug absorption study of tenofovir gel used daily in women who are in their third trimester of pregnancy, and women who are breastfeeding. More info…
MTN-009 Also called the HIV Drug Resistance Study, an observational study to assess the prevalence of and risk behaviors associated with HIV drug resistance in a representative population of women from KwaZulu-Natal, South Africa. More info…
MTN-011 A Phase I study that aims to determine the effect that vaginal intercourse may have on drug absorption and drug activity of tenofovir gel. The study will enroll approximately 40 couples at two U.S. sites.
MTN-013/IPM 026 A Phase I safety and drug absorption study of a vaginal ring containing either dapivirine, maraviroc or the two antiretroviral drugs combined. The study is the first clinical trial of a vaginal ring containing maraviroc and the first to test a vaginal ring with two active drugs. It is being conducted in collaboration with the International Partnership for Microbicides. More info…
MTN-014 A Phase II study to examine drug absorption patterns in both rectal and vaginal tissue when gel is applied either vaginally or rectally. The study will involve approximately 32 women at two sites – one in the U.S. and one in South Africa.
MTN-015 A long-term, observational study that seeks to understand the nature of HIV progression and treatment response in women who became infected while participating in an MTN trial of a topical microbicide or oral pre-exposure prophylaxis. More info…
MTN-016The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a first-of-its-kind observational study. More Info…
MTN-017 A Phase II rectal safety and adherence study of a reformulated version of - tenofovir gel and oral Truvada® that will include approximately 186 men who have sex with men and transgender women. The study, which is being developed, will be conducted at sites in the U.S., Peru, South Africa and Thailand. More Info…
MTN-018 (CHOICE) Committed to Having Options for Interventions to Control the Epidemic, an open-label follow-up study to VOICE designed to move forward if VOICE finds any of the products safe and effective. Because two interim reviews found both tenofovir tablets and tenofovir gel were not effective in VOICE, only the oral Truvada® tablet can be considered for CHOICE, provided VOICE results are favorable.
MTN-018B A proposed open-label sub-study to MTN-018 (CHOICE) for HIV-uninfected former VOICE participants who are breastfeeding.
MTN-018C A proposed open-label sub-study to MTN-018 (CHOICE) for HIV-uninfected former VOICE participants who are pregnant.
MTN-020 (ASPIRE) A Study to Prevent Infection with a Ring for Extended Use – is a Phase III safety and effectiveness trial of a vaginal ring containing the antiretroviral dapivirine that was launched in August 2012 and will enroll about 3,476 women at several sites in Africa. The dapivirine vaginal ring was developed by the International Partnership for Microbicides. More Info…
Completed Studies
HPTN 035 A multi-center clinical trial that evaluated 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 Africa and the United States. Results were announced in February, 2009. More info…
HPTN 059 A trial that assessed the safety and acceptability of the antiretroviral-based candidate microbicide tenofovir topical gel used either daily or before each act of sex in 200 HIV-negative women at three sites in India and the United States. More info…
MTN-001 A Phase II trial directly comparing the tablet and vaginal gel formulations of the antiretroviral drug tenofovir, looking at women’s adherence to and acceptance of three daily regimens – tenofovir gel, tenofovir tablet and the two together – and how the drug is absorbed by and distributed in the body. More info…
MTN-002 The first study of a candidate topical microbicide in pregnant women that aimed to understand if and to what extent pregnancy affects how the body absorbs the active drug in the antiretroviral-based microbicide tenofovir gel, and whether the drug transfers to the fetus. More info…
MTN-004 A study that evaluated the safety, acceptability and ease of use of the microbicide candidate VivaGel® in sexually active, HIV-negative women ages 18 to 24. More info…
MTN-006 A Phase I safety, acceptability and drug absorption study of tenofovir vaginal gel applied rectally and tenofovir tablets taken orally being conducted in collaboration with the University of California, Los Angeles (UCLA) through the Integrated Preclinical/Clinical Program for HIV Topical Microbicides, National Institute of Allergy and Infectious Diseases. More info…
MTN-007 A Phase I study designed to determine if rectal use of a reformulated version of tenofovir gel is safe and whether men and women would be willing to use it as a rectal microbicide. More info…
MTN-012/IPM 010 A Phase I study involving sexually abstinent men to assess the safety and tolerance of a vaginal microbicide containing the antiretroviral drug dapivirine when applied topically to the penis. The study is being conducted in collaboration with the International Partnership for Microbicides.
