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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 - 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.   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.   More info…

 

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 - 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 (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-037 - A Phase I study evaluating whether a microbicide gel called PC-1005 is safe for use in the rectum.  More info...

 

MTN-041 - A qualitative study taking place in Malawi, Uganda, South Africa and Zimbabwe that seeks 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 involves 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. Its results 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...

 

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 - 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...