Phase 3 Trials Begin for HIV Prevention Ring

Two trials in Africa are currently recruiting participants for large scale efficacy trials of a way for women to prevent HIV infection. ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) and The Ring Study are testing a vaginal ring with th ART dapivirine. Together the trials will include around 5,000 participants.

Dapivirine is an NNTRI antiviral developed to fight HIV. It works by preventing the virus from replicating and creating more viruses. The dapivirine ring is a small ring made of silicone and designed to be inserted into the vagina, similar to the contraception vaginal rings used in the US and Europe. Earlier trials found that medication from the dapivirine rings is absorbed into the cells of the vagina over the course of a month or more. Tests have also found that medication stays within the vagina and does not spread to other parts of the body.

The trials will run out of over a dozen sites in Africa, including in South Africa, Uganda and Malawi. They will run for approximately two years, ending in 2014. Results are expected to be published in late 2014 or early 2015.

Women participating in the study will have appointment at the study site each month where they will receive their ring for the month, and counseling on HIV prevention and family planning.

The dapivirine ring is the first large scale trial for a medication to prevent HIV infection which is not based on the ARV tenofovir. Truvada, a ART medication which combines tenofovir and emtricitabine, was recently approved by WHO and the FDA for use in preventing HIV infections among at-risk populations. A tenofovir based vaginal gel has been in testing to determine its effectiveness in preventing HIV infection in women. So far trials of the gel have had mixed results.

The International Partnership for Microbicides developed the dapivirine ring. The network is committed to finding methods of killing HIV that will prevent sexual transmission of the virus. If ASPIRE and The Ring Study are successful, IPM will be seeking approval to produce dapivirine rings for widespread use.

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