The nonprofit organization International Partnership for Microbicides, or IPM, recently announced the launch of a phase 1 trial assessing the safety and efficacy of its 3-month vaginal ring designed to prevent HIV and unintended pregnancy.
According to a press release, the multipurpose ring slowly and simultaneously releases the non-nucleoside reverse transcriptase inhibitor dapivirine to prevent HIV and the contraceptive hormone levonorgestrel. The ring builds on similar technology used for IPM’s monthly dapivirine-only ring, which is the first long-acting, self-initiated HIV prevention method that has shown in two phase 3 trials to safely reduce the risk for infection among sexually active women.
According to IPM, HIV and maternal mortality are the two leading causes of death among women of reproductive age. However, multiple studies have indicated that women are interested in using discreet rings for HIV or multipurpose prevention.
“HIV incidence and unmet contraceptive need continues to be alarmingly high, especially among women in developing countries,” Zeda Rosenberg, ScD, founder and CEO of IPM, told Infectious Disease News. “We need more options beyond the condom, an on-demand method that is often not realistic for women.”
For the phase 1 study, MTN-030/IPM 041, researchers will randomly assign approximately 24 healthy women aged 18 to 45 years who are not pregnant to receive a vaginal ring containing 200 mg of dapivirine and 320 mg of levonorgestrel, or a ring containing only 200 mg of dapivirine. The study, led by the NIH-funded Microbicide Trials Network, will be conducted at two sites in the U.S. — the University of Alabama at Birmingham and Magee-Womens Hospital of UPMC, a teaching hospital affiliated with the University of Pittsburgh. Results are slated for mid-2018.
“This first clinical trial of the dapivirine-contraceptive ring will collect important safety and pharmacokinetics data, as well as information on its acceptability to women, that will help us refine the ring’s formulation and, we hope, support its advancement to additional trials,” Rosenberg said.