Non-ARV/Non-Hormonal Dual-Purpose Monthly Vaginal Ring
The non-antiretroviral (ARV)/non-hormonal dual-purpose vaginal ring is being developed by the Oak Crest Institute of Science in Monrovia, Calif., as a method to protect women against both HIV and unplanned pregnancy for one month at a time. The ring, which is made of a soft and flexible silicone, is designed to be inserted and removed by women themselves.
Each of the two lobes in the ring contains a drug delivery cassette. One cassette contains the anti-HIV agent, a novel antiviral peptide (protein fragment) that blocks viruses from attaching to, penetrating and infecting healthy cells in the body. Animal and laboratory studies suggest the antiviral drug also has activity against herpes simplex virus (HSV) and human papillomavirus (HPV), in addition to HIV. The other cassette contains a novel hormone-free contraceptive called a soluble adenyl cyclase (sAC) inhibitor that impedes the movement of sperm and its ability to penetrate and fertilize eggs.
When placed inside the vagina, the ring is designed to continuously release both drugs during the one month it is worn, with both agents acting locally in the vaginal fluids.
The sAC inhibitor and the antiviral peptide are new drugs that have not yet been evaluated in human clinical trials. While similarly sized vaginal rings have been found to be safe and acceptable as either contraception (e.g., the NuvaRing) or for HIV prevention (e.g., the monthly dapivirine ring), the design of Oak Crest’s dual-purpose ring, with its two drug delivery cassettes, is unlike other rings studied to date. As such, before conducting a Phase1 trial, researchers are evaluating the safety and acceptability of two placebo rings (with neither cassette containing active drug) that differ slightly in their flexibility and stiffness. The MATRIX-003 study will help inform the final design of the ring to be evaluated in clinical trials moving forward, including a first-in-human trial of the ring delivering both active ingredients.
The Oak Crest Institute of Science is collaborating with scientists at Weill Cornell Medicine, the Medical College of Cornell University, and other partners in the development of the dual-purpose vaginal ring, which is sometimes referred to as the OneRing.
MATRIX News Releases
Prototypes of a novel vaginal ring design being put to the test in a study that will inform final design of a dual-purpose ring for prevention of both HIV and unplanned pregnancy
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Non-ARV/Non-hormonal Contraceptive Dual-Purpose Vaginal Ring and the MATRIX-003 study