Microbicide Trials Network

Studies


Below are brief descriptions of ongoing and planned studies, followed by a listing of completed trials. Where indicated, there is additional information (e.g., news releases, fact sheets) available for many of these studies. This information can also be accessed by clicking on the study name where listed in the News Room menu (on right).

           

To access study protocols and other study-related materials, please go to this website’s main Studies tab.

 

Ongoing and Planned Studies

    

MTN-015 - A long-term, observational study that aims to track the nature of HIV progression and treatment response among women who acquired HIV while participating in a MTN “parent study”.  More info…

    

MTN-016 - The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) seeks to learn whether HIV prevention products containing ARVs can affect a woman’s pregnancy outcome or her baby’s general growth and development.  More Info…

   

MTN-025 (HOPE) – HIV Open Label Prevention Extension – An open-label follow-on trial to ASPIRE in which former ASPIRE participants are offered the opportunity to use the dapivirine ring (there is no placebo) in the context of a study that will gather additional information on the ring’s safety, how women use the ring knowing that it can help reduce their risk of HIV and the relationship between adherence and HIV protection.   More Info…

 

MTN-026/IPM 038 – A Phase I study that will evaluate whether a gel containing dapivirine is safe for use in the rectum. The study will help determine whether further testing on the safety and acceptability of dapivirine gel as a potential rectal microbicide can be conducted in a larger population.

 

MTN-029/IPM 039 – The first study of its kind involving the dapivirine vaginal ring, MTN-029/IPM 039 will determine whether drug released from the dapivirine ring into the vagina gets absorbed by breastmilk.   More info…

 

MTN-030/IPM 041 – A Phase I trial of a vaginal ring containing the ARV drug dapivirine and the contraceptive hormone levonorgestrel, an important first step toward developing a product for women that could both protect against HIV and prevent unplanned  pregnancy.

         

MTN-032 – A qualitative study that looks to better understand women’s use of the dapivirine ring in both ASPIRE and HOPE and if and how adherence patterns differ between ASPIRE, a placebo-controlled trial, and the HOPE open-label extension trial in which all women are offered the dapivirine ring, yet may choose not to accept it.   More info…

 

MTN-033/IPM 044 – A Phase I study that will look at the safety and distribution of dapivirine gel when administered rectally like a lubricant (without an applicator) to determine whether enough drug  is delivered in the tissue to feasibly provide HIV protection. 

 

MTN-034/IPM 045 – A Phase IIa trial that seeks to understand the HIV prevention needs and preferences of adolescent girls and young women, who are among those at highest risk of HIV in sub-Saharan Africa in a design that will evaluate both the monthly dapivirine ring and daily use of Truvada as oral pre-exposure prophylaxis (PrEP).   More info…

  

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…