Studies

Current and Planned Studies

MTN-001 [1] 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… [1]

MTN-003 (VOICE) [2] The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic – is evaluating 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 vaginal daily or taking an ARV tablet once a day. More info… [2]

MTN-003B [3] (VOICE B) The Bone Mineral Density Substudy 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… [3]

MTN-005 An expanded safety and acceptability study of a nonmedicated vaginal ring made of a silicone elastomer in 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 Population Council.

MTN-006 [4] 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… [4]

MTN-007 A Phase I trial involving both men and women that will evaluate safety and acceptability of the vaginal microbicide tenofovir topical gel when applied rectally.

MTN-008 A study in development that will evaluate the safety and drug absorption associated with daily use of tenofovir gel in pregnant and lactating women.

MTN-009 An observational study in development that will look at the prevalence of HIV drug resistant mutations and drug resistant virus in communities around trial sites in southern Africa, seeking to understand how the intersection of treatment and prevention strategies might impact individual response to these interventions and public health more broadly.

MTN-015 [5] 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… [5]

MTN-016 The 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.

Completed Studies

HPTN 035 [6] 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… [6]

HPTN 059 [7] 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… [7]

MTN-002 [8] 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… [8]

MTN-004 [9] 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… [9]