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NIH to Test Dapivirine Vaginal Ring for HIV Prevention in Women
Results of the study 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 NIH––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, MD. “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 study team will enroll HIV-uninfected women aged 18 to 45 years in Malawi, South Africa, Uganda, Zambia, and Zimbabwe. The participants will be randomly assigned to receive either a silicone ring containing 25 mg 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 4 weeks for at least 12 months.
During monthly 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 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.
Read the full news release from the NIH.