Microbicide Trials Network

Completed Studies

MTN-001 - A Phase II trial that looked at differences in how the ARV tenofovir gets absorbed in the body as either an oral tablet or a vaginal gel, as well as women’s preferences or ability to adhere to daily regimens of each approach.  Results and more info…

      

MTN-002 - The first study of a vaginal microbicide in pregnant women that aimed to understand if and to what extent pregnancy affects how the body absorbs the active drug in tenofovir gel, and whether the drug transfers to the fetus.  Results and more info…

      

MTN-003 (VOICE) - The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic – was a major trial that evaluated the safety and effectiveness of two antiretroviral-based approaches for preventing sexual transmission of HIV in women: daily use of an ARV tablet (tenofovir or Truvada®) or daily use of a vaginal gel (tenofovir gel).  Results and more info…

     

MTN-003B (VOICE B) - The Bone Mineral Density Sub-study was an observational study in a subset of participants in the VOICE study designed to explore the potential effects of oral study products on bone mineral density.   More info…

     

MTN-003C (VOICE C) - The Community and Adherence Sub-study aimed to identify specific factors within a participant’s household, social environs or broader community that may have influenced her ability and willingness to follow the daily regimens were tested in VOICE.  Results and more info…

                          

MTN-003D (VOICE D) - A sub-study of VOICE (MTN-003) looking to better understand women’s actual use of study products and sexual behavior during their participation in VOICE.  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.  Results and 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 was conducted at three sites – one in India and two in the United States, in collaboration with the Population Council.  Results have not yet been reported. Data analysis is currently underway.

  

MTN-006 - (RMP-02/MTN-006) A Phase I safety, acceptability and drug absorption study of tenofovir vaginal gel applied rectally and tenofovir tablets taken orally that was 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.  Results and more info…

 

MTN-007 - A Phase I study designed to determine if rectal use of a reformulated version of tenofovir gel (reduced glycerin formulation) is safe and whether men and women would be willing to use it as a rectal microbicide.  Results and more info…

  

MTN-008 - A phase I expanded safety and drug absorption study of tenofovir gel used daily in women in their third trimester of pregnancy, and women who are breastfeeding.  Results are not yet available.  Results and more info…

    

MTN-009 - Also called the HIV Drug Resistance Study, an observational study that assessed the prevalence of and risk behaviors associated with HIV drug resistance in a representative population of women from KwaZulu-Natal, South Africa.  Results and more info…

  

MTN-011 - - A Phase I study that aimed to determine the effect vaginal intercourse may have on drug absorption and drug activity of tenofovir gel. The study, which was conducted at two U.S. sites,  enrolled 24 couples. Study results, presented in October 2014, showed that drug levels were highest when tenofovir gel was used one hour before and one hour after sex, suggesting that the timing of gel use relative to sex impacts the drug’s absorption and activity. at two U.S. sites.

       

MTN-012/IPM 010 - A Phase I study involving that assessed the safety and tolerance of a vaginal microbicide containing the antiretroviral drug dapivirine when applied topically to the penis of sexually abstinent men. The study, which was conducted in collaboration with the International Partnership for Microbicides, found the gel safe and well tolerated.

 

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 was the first clinical trial of a vaginal ring containing maraviroc and the first to test a vaginal ring with two active drugs. Was conducted in collaboration with the International Partnership for Microbicides.  Results and more info…

 

MTN-014- A Phase I study to examine drug absorption patterns in both rectal and vaginal tissue when a reduced glycerin formulation of tenofovir gel is applied either vaginally or rectally.The study enrolled 14 women at a U.S. based clinical research site.  Results, reported in July 2015, demonstrated that when tenofovir gel was applied into the vagina, a low amount of active drug was distributed to the rectum and, similarly, when the gel was applied into the rectum, a low amount of active drug was distributed to the vagina.  More info…

 

MTN-017 - The first Phase II trial of a rectal microbicide, MTN-017 designed to evaluate the rectal safety, drug absorption and acceptability of a reduced glycerin formulation of tenofovir gel, as well as oral Truvada, among men who have sex with men and transgender women at several international sites.  Results and more Info…

     

MTN-020 (ASPIRE) - A Study to Prevent Infection with a Ring for Extended Use – was a Phase III trial involving 2,629 women from four African countries that found a monthly vaginal ring containing the antiretroviral dapivirine was safe and helped protect against HIV.  Results and more Info…

 

MTN-023/IPM 030 - A Phase I safety study of the dapivirine vaginal ring in adolescent girls that was conducted at six U.S. research sites in collaboration with the National Institutes of Health-funded Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions. As with MTN-024/IPM 31, the study was designed to collect data that regulatory bodies will require when considering whether to approve the dapivirine ring for HIV prevention.   More info…

  

MTN-024/IPM 031 - A Phase I safety of the dapivirine ring that found it was safe and well-tolerated in post-menopausal women.  The study was conducted at three sites in the U.S., and as with MTN-023/IPM 30, was designed to collect data that regulatory bodies will require when considering whether to approve the dapivirine ring for HIV prevention.

 

MTN-027 – Along with its companion study, MTN-028, MTN-027 is the first clinical trial to test a type of ARV called an integrase inhibitor as a potential microbicide.  A Phase I trial, MTN-027 looked at the safety of three vaginal rings: one that contains the integrase inhibitor MK-2048; a second ring containing vicriviroc (MK-4176), which is a CCR5-receptor antagonist; and a third ring that contains both active drugs. Results are anticipated in late 2016 or early 2017. 

 

MTN-028 – A Phase I trial that evaluated two vaginal rings, each containing a different dose of the same two ARV drugs – a CCR5-receptor antagonist called vicriviroc (MK-4176) and an integrase inhibitor, MK-2048. While the MTN-028seeks to understand the optimal doses of MK-4176 and MK-2048 needed to achieve concentrations of drug in tissue that could feasibly provide HIV protection.  Results are anticipated in late 2016 or early 2017.

    

See also information on these completed trials:

 

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 U.S.  Results and more info…

       

HPTN 059 - A trial that assessed the safety and acceptability of tenofovir gel used either daily or before each act of sex in 200 HIV-negative women at three sites in India and the U.S.  Results and more info…