A new option for preventing HIV in women?

• Monthly vaginal ring being tested in NIH-funded studies

• Active agent is antiretroviral drug dapivirine

Researchers are about to launch a large, multinational Phase III clinical trial to test the safety and effectiveness of a vaginal ring containing the experimental antiretroviral (ARV) drug dapivirine. The ring is intended to provide women with another means to prevent HIV acquisition through vaginal intercourse.

The trial, known as, “A Study to Prevent Infection with a Ring for Extended Use (ASPIRE),” or MTN-020, is expected to involve almost 3,500 women aged 18 to 45 from 5 countries: Malawi, South Africa, Uganda, Zambia, and Zimbabwe. The women will receive either a vaginal ring containing 25 mg dapivirine or a placebo ring in a double-blind fashion. They will be instructed to replace the ring every 4 weeks for at least 1 year.

Because half of the world’s HIV-infected population is female and many cannot negotiate condom use with their partners, the hope is that the dapivirine vaginal ring would provide these women with a way to take control and protect themselves from HIV infection and with an alternative to microbicidal gels and ARV tablets.

In addition to efficacy and safety, the authors of the study hope to assess whether women and their partners like using the ring and the extent to which women are able and likely to use the product. It will be performed at the same time as another trial, The Ring Study, led by the International Partnership for Microbicides (IPM), which developed the ring. The investigators hope that the 2 studies together will provide sufficient evidence to support licensure of the product. Results are expected in early 2015.

Funding for The Ring Study is from the National Institute of Allergy and Infectious Disease, the Eunice Kennedy Shriver National Institute on Child Health and Human Development, and the National Institute of Mental Health.

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