CONRAD Launches First-Ever Multipurpose Vaginal Ring Clinical Trial

ARLINGTON, Va., Nov. 17, 2014 /PRNewswire/ -- CONRAD, a leading non-profit reproductive health organization, today announced the launch of the first-ever study testing an intravaginal ring engineered to provide contraception, as well as reduce HIV and herpes infections.  This study, funded by the U.S. Agency for International Development (USAID) and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), examines a multipurpose prevention technology (MPT) ring that contains tenofovir (TFV), an antiretroviral that has the potential to prevent HIV replication in susceptible cells and protect against HSV-2 (herpes) infection, plus levonorgestrel (LNG), an established hormonal contraceptive.  

A total of 50 women at Eastern Virginia Medical School (EVMS), the parent organization of CONRAD, and at Profamilia, a clinical site in the Dominican Republic, are currently being enrolled and randomly assigned to three different groups: one group will use the ring containing tenofovir plus levonorgestrel, another group will use a ring containing tenofovir only, and a third group will use a placebo ring. The active product rings are designed to be effective for up to three months. Each woman will participate in the study for approximately 2-3 months, and use her assigned ring for up to 3 weeks. Participants began using study product for this Phase I study, which is assessing the safety, acceptability, and pharmacokinetics / pharmacodynamics (looking at drug concentrations in the body and the effects of the drugs and how they work in the body) of the TFV/LNG ring and TFV-only ring.

CONRAD Scientific and Executive Director Gustavo Doncel, Ph.D, M.D. said, "Despite the successes the HIV prevention world has seen over the past several years, there remains an urgent need for new methods of HIV prevention in the developing world, particularly in sub-Saharan Africa, where single women under 25 are at high risk of becoming infected, but at the same time the least likely to use some form of protection like condoms or a daily pill. An MPT ring that offers contraception, HIV and herpes protection, is woman-initiated, and potentially effective for up to 90 days would be a game changer for the reproductive health of women around the world.  And since adherence to drugs is an ongoing issue in all areas of medicine, our hope is that a long acting MPT ring that can be effective for up to 90 days can offer a solution to this problem." 

A vaginal gel containing 1% tenofovir was tested in a South African trial called CAPRISA 004, and provided evidence that women could reduce HIV and herpes infections when using a topical product that is inserted before and after sex.  To date, tenofovir is the only drug tested in a late phase human study that has been shown to be effective in reducing these sexually transmitted infections. Tenofovir has a potential dual effect in preventing herpes simplex virus (HSV-2).  Since women with genital herpes are much more likely to become infected with HIV, the additional protection of tenofovir gel against herpes creates a second mechanism whereby the gel may have a bigger impact in preventing HIV.

CONRAD developed tenofovir gel with funding from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID) and Gilead, who provided the active ingredient.  The MPT ring was developed with support from USAID's Office of Population and Reproductive Health and PEPFAR funding.

Prior to initiating the Phase I study in women, CONRAD researchers, in collaboration with Dr. Patrick Kiser at Northwestern University, performed clinical and pharmacokinetic studies of the ring in rabbits and sheep, and compared drug levels to those seen with use of tenofovir gel. The studies found that concentrations of tenofovir in the target tissue delivered from the ring are similar to or higher than after a gel application. In addition, release of the contraceptive agent was consistent with previous concentrations tested to be efficacious in women.

CONRAD (www.conrad.org) was established in 1986 and is a Division of the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA, where it has laboratories and a clinical research center. Thanks to our funders, which include PEPFAR, the U.S. Agency for International Development and the Bill and Melinda Gates Foundation, CONRAD is a leader in researching and developing new contraceptive options and products to prevent HIV and STIs. The main office is located in Arlington, VA and we collaborate with academic and research institutions around the world. 

SOURCE CONRAD

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http://www.conrad.org