The International Partnership for Microbicides, or IPM, announced the launch of a phase 1 clinical trial that will evaluate a vaginal ring that slowly releases the non-nucleoside reverse transcriptase inhibitor dapivirine over 3 months to prevent HIV infection in women.
The ring builds on similar technology used for IPM’s monthly dapivirine 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 a press release.
The monthly ring is currently undergoing regulatory review in Europe, and IPM plans on submitting a new drug application for the monthly ring to the FDA in 2018. However, the availability of a 3-month ring could increase convenience and reduce annual costs, the release said.
“A safe and effective 3-month ring may be appealing to some women for its long-acting nature, which would help fill a gap in the existing HIV prevention toolkit,” Zeda Rosenberg, ScD, founder and CEO of IPM, told Infectious Disease News.
The phase 1 trial, MTN-036/IPM 047, is being conducted by the NIH-funded Microbicide Trials Network (MTN) and IPM at two sites in the United States — the University of Alabama at Birmingham and Bridge HIV, a San Francisco Department of Health facility affiliated with the University of California, San Francisco. Researchers will randomly assign approximately 48 healthy adult women who are not pregnant to receive a 3-month ring containing 100 mg of dapivirine, a 3-month ring containing 200 mg of dapivirine, or a 1-month ring containing 25 mg of dapivirine for 13 weeks. The primary objective is to gather safety and pharmacokinetic data. However, researchers will also assess product acceptability, adherence and changes in the vaginal microenvironment, according to the release. Results will likely be available late next year.
In addition to the 3-month and 1-month dapivirine vaginal rings, IPM is developing other products, including a 3-month multipurpose vaginal ring that prevents both HIV and unintended pregnancy. The multipurpose ring recently completed its first clinical trial. Results are slated for 2018.
“No single product will be right for all women — women need a range of products that meet their needs, which may change throughout their lives,” Rosenberg said. “Expanding women’s options increases the likelihood they will find one that works in the context of their lives, so that they can stay protected.” – by Stephanie Viguers
Disclosure: Rosenberg is the founder and CEO of IPM.