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-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, and in particular to understand why women enrolled and remained in VOICE yet so few adhered to product use.  More info…
     
MTN-011 - A Phase I study that aims to determine the effect 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-014- A Phase II 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 will involve approximately 14 women at a U.S. based clinical research site.
  
MTN-015 - A long-term, observational study that seeks to understand the nature of HIV progression and treatment response in women who become infected while participating in a MTN trial. More info…
    
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. 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. More Info…
     
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 opened in August 2012 and plans to enroll up to 3,476 women at 15 sites in Africa. More Info…
  
MTN-023/IPM 30 - A Phase I safety study of the dapivirine vaginal ring in adolescent girls to be conducted at four 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 is designed to collect data that regulatory bodies will require when considering whether to approve the dapivirine ring for HIV prevention.
  
MTN-024/IPM 31 - A Phase I safety of the dapivirine ring in post-menopausal women taking place at three sites in the U.S. As with MTN-023/IPM 30, the study is designed to collect data that regulatory bodies will require when considering whether to approve the dapivirine ring for HIV prevention.
 
MTN-025 - An open-label trial that would move forward if the dapivirine ring is found to be effective in ASPIRE. HIV-negative women who participated in ASPIRE would be invited to enroll and have access to the ring as part of the study.
  
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. Results have not yet been reported.  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-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.
  
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. 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. More info…
  
MTN-012/IPM 010 - A Phase I study involving sexually abstinent men that assessed the safety and tolerance of a vaginal microbicide containing the antiretroviral drug dapivirine when applied topically to the penis. Conducted in collaboration with the International Partnership for Microbicides. Results were reported in 2013.
 
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…
 
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…