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 Studies link underneath the News menu.

          

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

 

Ongoing and Planned Studies

 

MTN-016 (EMBRACE) - Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure – A study that seeks to learn whether HIV prevention products containing ARVs can affect a woman’s pregnancy outcome or her baby’s general growth and development. The study involves the creation of a database of health information collected from women who unintentionally became pregnant while participating in an MTN trial, or who participated in MTN pregnancy or breastfeeding studies. Health information about their babies is also included.  More Info…

 

MTN-034 (REACH) - 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…

 

MTN-035 (DESIRE) - an open label crossover study to systematically examine multiple placebo methods for delivering drugs to help prevent HIV from anal sex.  More info…

 

MTN-038 - A Phase 1, Randomized, Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir.  More info…

 

MTN-039 - A Phase I study designed to evaluate the safety, acceptability and concentrations of drug in the rectal tissue of a fast-dissolving rectal insert containing the antiretroviral drugs tenofovir and elvitegravir. The study will include 20 men and women (cisgender or transgender) at two sites in the U.S.

 

MTN-042 (DELIVER) - A Phase IIIb open-label study being planned that will evaluate the dapivirine vaginal ring and Truvada as daily PrEP (pre-exposure prophylaxis) in pregnant women to determine whether use of these products is safe for both women and their infants. The study will be conducted at trial sites in Malawi, Uganda, South Africa and Zimbabwe. Of the 750 women who will be enrolled, 500 will use the vaginal ring. The study is the first to be conducted of the dapivirine ring during pregnancy.  More info...

 

MTN-043 (B-PROTECTED)  - A Phase IIIb open-label trial under development that will evaluate whether the dapivirine ring and Truvada as daily PrEP are safe to use by women who are breastfeeding. The study, which will be conducted at trial sites in Malawi, Uganda, South Africa and Zimbabwe, will enroll up to 200 mothers and their breastfed babies. The MTN has already conducted a study (MTN-029/IPM 039) that involved U.S. women who were no longer nursing their babies but still producing milk, which found dapivirine was absorbed at very low concentrations in breastmilk.  More info...

 

MTN-044/IPM 053/CCN019 - A Phase I study of a 90-day vaginal ring containing the antiretroviral dapivirine and the contraceptive hormone levonorgestrel to prevent both HIV and unintended pregnancy. The study, currently enrolling 24 women at one site in the U.S., will evaluate the safety and acceptability of the ring.

 

MTN-045 - A cross-sectional study using questionnaires and other measures to assess couples’ preferences for dual purpose prevention products to prevent unintended pregnancy and HIV infection. The study findings will inform the future design and delivery of products.

 

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 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.  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-015 - A long-term, observational study tracking the nature of HIV progression and treatment response among women who acquired HIV while taking part in an MTN “parent study” testing different antiretroviral (ARV)-based products for the prevention of HIV.  MTN-015 will help researchers understand the impact of using these products on the natural history and clinical course of HIV and on the prevalence and patterns of HIV drug resistance over time.  Results from MTN-015 have been published as the parent studies have been completed and reported results.  MTN-015 results from participants in the HOPE study are anticipated in late 2019 or early 2020.  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-025 (HOPE) - HIV Open Label Prevention Extension – An open-label follow-on trial to ASPIRE in which former ASPIRE participants were offered the opportunity to use the dapivirine ring (there was no placebo) in the context of a study. HOPE is building on the results of ASPIRE by gathering 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. The study also seeks to understand why the ring may work well as an HIV prevention strategy for some women but not for others. For this reason, former participants were enrolled in HOPE even if they did not wish to use the ring. Final study results will be reported in mid-2019.   More Info…

 

MTN-026 - A Phase I study that evaluated 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.  Results are anticipated in late 2019.   More info...

 

MTN-027 - Along with its companion study, MTN-028, MTN-027 was 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 contained the integrase inhibitor MK-2048; a second ring containing vicriviroc (MK-4176), which is a CCR5-receptor antagonist; and a third ring that contained both active drugs. Results, reported in 2019, found the rings to be safe and acceptable.

 

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. MTN-028 sought 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. According to results, reported in 2019, both doses of rings were safe and well tolerated. MK-4176 and MK-2048 were detectable in plasma and tissues in higher amounts in the higher dose ring compared to the lower dose ring.

 

MTN-029/IPM039 - The first study of its kind involving the dapivirine vaginal ring, MTN-029/IPM 039 found that very low concentrations of dapivirine released from the ring into the vagina were absorbed by breastmilk in lactating women. Approximately 16 women who were no longer breastfeeding but were still producing breast milk were enrolled into the study and used the ring for 14 consecutive days. Results supported the development of future studies involving both breastfeeding mothers and their infants, particularly, the B-PROTECTED (MTN-043) study.   More info…

 

MTN-030/IPM 041 - A Phase I trial of a vaginal ring containing the ARV drug dapivirine and the contraceptive hormone levonorgestrel that found the ring was well-tolerated with no safety concerns. The study represented an important first step toward developing a product for women that could both protect against HIV and prevent unintended pregnancy.   More info…

 

MTN-032 - A qualitative study 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 were offered the dapivirine ring, yet some chose not to accept it.  MTN-032 was conducted in two parts. Phase I, which reported results in 2018, involved 187 former ASPIRE participants who had been assigned to use the dapivirine ring and who took part in either a focus group or in-depth interview.  Among those Phase I participants who opted to enroll in HOPE, 115 took part in a single in-depth interview in Phase 2, whose results are expected in mid to late 2019.  MTN-032 was conducted at six of the 15 clinical research sites for ASPIRE and HOPE.   More info…

 

MTN-033 - A Phase I study that looked 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.  Results are expected in late 2019.

 

MTN-036/IPM 047 - A Phase I open label study that assessed the safety and concentrations of drug in the tissue when using three dapivirine vaginal rings containing either 25 mg or 200 mg of the drug dapivirine and made of two different types of silicone polymer.  The study, whose results are expected mid to late 2019, included 49 women in the U.S.

 

MTN-037 - A Phase I study that evaluated whether a microbicide gel called PC-1005 is safe for use in the rectum. The study, which included 12 HIV-negative cisgender and transgender men and women at two sites in the U.S., will help determine whether further testing on the safety and acceptability of PC-1005 as a potential rectal microbicide for preventing HIV and other sexually transmitted infections (STIs) can be conducted in a larger population. Results are anticipated by late 2019.  More info...

 

MTN-041 - A qualitative study that took place in Malawi, Uganda, South Africa and Zimbabwe to understand community belief systems and attitudes that may affect women’s perceptions about and potential interest in using the monthly dapivirine vaginal ring or daily PrEP during pregnancy and breastfeeding. The study involved group discussions with women, male partners and mothers and mothers-in-law of pregnant and breastfeeding women and interviews with community leaders, healthcare providers, midwives and traditional birth attendants, among others. The results, expected in late 2019,  will help inform implementation of both the MTN-042 study in pregnant women, and the MTN-043 study, which will enroll women who are breastfeeding and their babies.  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…

 


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