Dapivirine Ring: Phase III Results
Overview of results: Two large clinical trials — The Ring Study and ASPIRE — announced in Feb. 2016 that a monthly vaginal ring containing the antiretroviral drug dapivirine can help prevent HIV in women and is safe for long-term use. Developed by IPM over the past 10 years, the ring reduced infections by approximately 30 percent overall, with strong trends toward higher efficacy with more consistent ring use. Notably, new analyses announced in July 2016 found that, among women who appeared to use the monthly ring consistently, HIV risk was cut by at least 56 percent — a statistically significant finding. Additional subgroup analyses suggest the product reduced HIV risk by 75 percent or more with near-perfect use.
Next steps for the ring: This is the first time a microbicide to prevent HIV has confirmed statistically significant efficacy across two Phase III studies. As the first long-acting HIV prevention method, the dapivirine ring could be an important new self-initiated option for women, who bear the greatest burden of the global HIV/AIDS epidemic. IPM, also the regulatory sponsor for the ring, will apply for regulatory approval to license the product. Two open-label extension studies are now underway to provide the ring to former Phase III trial participants and help determine how the ring could fit into women’s lives.
Learn more about the results from the Phase III dapivirine ring studies:
- IPM press release on new data analyses (July 2016): IPM’s dapivirine ring may offer significant HIV protection when used consistently, new data analyses suggest
- IPM press release on ring results (Feb. 2016): Two Large Studies Show IPM’s Monthly Vaginal Ring Helps Protect Women Against HIV
- MTN press release on ring results (Feb. 2016): Dapivirine vaginal ring helped protect women against HIV in ASPIRE Phase III trial
- IPM press release on additional analyses (July 2016): IPM’s dapivirine ring may offer significant HIV protection when used consistently, new data analyses suggest
- MTN press release on additional analyses (July 2016): Used consistently, monthly vaginal ring may be highly effective against HIV in women, suggest new analyses from ASPIRE
- Fact sheet: Sister Studies: The Ring Study and ASPIRE
- Frequently Asked Questions
- The Ring Study: CROI 2016 abstract and presentation
- ASPIRE: CROI 2016 abstract and presentation
- Fact sheet: IPM: Pioneering HIV prevention options for women