Phase 3 trial of vaginal ring to prevent HIV closes
A major trial testing the efficacy and safety of a vaginal ring containing the antiretroviral medication dapivirine has been completed, according to a press release from the NIH-funded Microbicide Trials Network. Results are expected early next year.
“We are hopeful that the women who took part in ASPIRE ... found the ring acceptable to use,” Thesla Palanee-Phillips, PhD, the trial’s protocol co-chair and director of clinical trials at Wits Reproductive Health and HIV Institute, Johannesburg, South Africa, said in the release. “In order to curb the rate of HIV infections in young African women, we need to find a prevention method that is easily incorporated into their lives. The dapivirine ring has enormous potential to be that method.”
The ASPIRE trial — or A Study to Prevent Infection with a Ring for Extended Use — is a phase 3, randomized, double blind, placebo-controlled study that began in August 2012 and enrolled 2,629 women from 15 sites in South Africa and other parts of Africa, according to research published in PLoS ONE.
Jared Baeten, MD, P h D, professor of allergy and infectious disease, epidemiology and global health at the University of Washington, served as protocol co-chair and led the ASPIRE trial for the Microbicide Trials Network.
Study participants had to have engaged in sex at least once in the 3 months before screening and be HIV uninfected, according to Baeten and colleagues. Forty-three percent reported not knowing the HIV status of their primary partner, and nearly one-quarter had an STD (chlamydia, 12%; trichomoniasis, 7%; gonorrhea, 4%; and syphilis, 1%).
Participants were assigned either 25-mg dapivirine rings or placebo rings every 4 weeks and used them for at least 1 year. The researchers anticipate that women will report finding the monthly treatment a discreet, convenient and effective way to prevent HIV.
The developer of the dapivirine ring — International Partnership for Microbicides (IPM) — is conducting a phase 3 trial called The Ring Study to determine the long-term efficacy and safety of the ring, according to the release. The 1,959 South African and Ugandan women enrolled in the study were encouraged to use the rings for 2 years.
Assuming the results of ASPIRE are promising, MTN plans to conduct an open-label trial called HOPE (HIV Open-label Prevention Extension). IPM will seek regulatory approval to license the dapivirine ring based on results of both ASPIRE and The Ring Study, as well as supporting studies. – by David Jwanier
Disclosure: The researchers report no relevant financial disclosures.