Multi-purpose Vaginal Ring Phase I Trial Initiated
The International Partnership for Microbicides (IPM) has announced the start of a Phase I clinical trial of a vaginal ring to prevent HIV and unintended pregnancy. The randomized, double-blind study marks the first time a vaginal ring containing both an antiretroviral drug (dapivirine) and levonorgestrel, a contraceptive hormone, will be tested in humans. As designed, the ring would slowly and simultaneously release both drugs for a period of three months. The study’s primary aim is to evaluate the ring’s safety and pharmacokinetics. The study will also assess product acceptability. Results of the trial, expected in mid-2018, will inform next steps for the ring’s formulation.
The study, funded through the National Institutes of Health’s Microbicide Trials Network, will be conducted at sites at the University of Alabama at Birmingham and Magee-Womens Hospital at the University of Pittsburgh Medical Center.