Groups Moving Forward to Develop AIDS Gel

Several groups working to develop a gel to protect women from HIV reported favorable results from a meeting last week with the US Food and Drug Administration. The developers said FDA informed them it would require only limited new data about the product's safety and efficacy before considering whether to license it.

"[FDA] gave it what is called fast-track designation," said Dr. Henry Gabelnick, executive director of CONRAD, a division of the Eastern Virginia Medical School-Norfolk. "That means you can report data on a rolling submission - you don't have to wait and put everything together. Then they have six months to review the data."

Researchers at July's 18th International AIDS Conference in Vienna were told that the gel, which contains Gilead Sciences' AIDS drug tenofovir, reduced HIV infections among women by 39 percent in a South African trial lasting more than two and a half years. Partnering with CONRAD on the study were the Center for Program Research for AIDS in South Africa (CAPRISA) and US-based Family Health International.

While researchers await a final report on that study, a second one called VOICE (Vaginal and Oral Interventions to Control the Epidemic) has been launched with US funding by the Microbicide Trials Network. FDA will want to examine the results of VOICE, which are due in 2013 or 2014, before considering the gel's approval. FDA also has requested data on how well the gel works in adolescents and post-menopausal women.

Gabelnick said CONRAD already is in negotiations with a South African company to lay the groundwork for manufacturing the gel through a public-private partnership. "We are trying to do things simultaneously to the extent that it could be done," Gabelnick said.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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