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Groups moving forward to develop AIDS gel

Groups developing a gel to protect women from the AIDS virus say they are moving ahead to develop the product that was hailed as "groundbreaking" after a study on its effectiveness was released in July.

The developers, who met last week with the U.S. Food and Drug Administration, said the FDA informed them it would only require a limited amount of new information about the gel's safety and efficacy before considering licensing the product.

The gel, containing Gilead Sciences AIDS drug tenofovir, reduced HIV infections in women by 39 percent over two and a half years in a trial in South Africa that was called "groundbreaking by the World Health Organisation.

The FDA would require more information on whether the gel works and is safe, but will help speed up the process, said Dr. Henry Gabelnick, executive director of CONRAD, one of the groups developing the gel.

"They gave it what is called fast-track designation," Gabelnick said in a telephone interview. "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."

The need for such a gel is compelling -- most infections with the AIDS virus are in Africa and most new cases are among women infected during sex with men. The human immunodeficiency virus that causes AIDS infects 33 million people globally and has killed 25 million.

There is no vaccine and no cure.

Condoms can protect women and men but many African men refuse to use them and often a married woman is trying to conceive a child but risks being infected by her husband.

A gel, cream or drug-releasing ring called a microbicide could help protect against HIV while allowing a woman to get pregnant, and, if necessary, she could use the product without letting her partner know.
 
 

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