Researchers will launch a large, multinational clinical trial this month to test the effectiveness and extended safety of a vaginal ring containing an experimental antiretroviral drug to prevent HIV infection in women.
With a projected 3,476 participants in five countries, the MTN 020 study, otherwise known as, "A Study to Prevent Infection with a Ring for Extended Use (ASPIRE)," aims to determine whether the drug dapivirine can safely prevent HIV infection when continuously released in the vagina from a silicone ring replaced once a month. Results are expected in early 2015.
The National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute on Child Health and Human Development, and the National Institute of Mental Health, all part of the National Institutes of Health, are funding the trial, which is sponsored by the International Partnership for Microbicides (IPM).
"Developing scientifically proven forms of HIV prevention that women can control is essential," said NIAID Director Anthony S. Fauci, M.D. "Because the vaginal ring is a long-acting intervention, it has a potential added benefit in that women may find it relatively easy to use."
The ASPIRE trial will be led by protocol chair Jared Baeten, M.D., Ph.D., associate professor of global health at the University of Washington in Seattle; and protocol co-chair Thesla Palanee, Ph.D., director of network trials at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa.
Half of the world's HIV-infected population is female; in Africa, 60 percent of HIV-infected adults are women. Most women who acquire HIV do so through unprotected sex.
Because many women cannot negotiate male condom use with their sexual partners, women need forms of HIV prevention that they can implement independently and will use regularly.
The dapivirine vaginal ring was developed by IPM as a discreet, convenient, long-acting option to help meet this need.
The ASPIRE study team will enroll HIV-uninfected women ages 18 to 45 in Malawi, South Africa, Uganda, Zambia and Zimbabwe. The participants will be assigned at random to receive either a silicone ring containing 25 milligrams of dapivirine or a placebo silicone ring.
Neither the participants nor the study team will know who receives which type of ring. Staff will instruct participants to insert a new ring every four weeks for at least 12 months.
During monthly study visits, the women will be tested for HIV and pregnancy and will receive condoms, counseling on how to reduce their risk of becoming infected with HIV and other sexually transmitted pathogens, and a new silicone ring.
The investigators and an independent data and safety monitoring board will carefully review the safety and HIV status of the participants.
Women who become infected with HIV during the study will be told to discontinue using the silicone ring and will be referred to local medical care and support services.
The number of new HIV infections in the dapivirine and the placebo groups will be compared.
The NIH-funded Microbicide Trials Network (MTN) will conduct the ASPIRE study through grant number UM1AI068633-06. IPM is providing the dapivirine silicone vaginal ring for this trial.