Food and Drug Administration Fast-Tracks Anti-HIV and Herpes Gel
January 19, 2006
The Food and Drug Administration has granted fast-track status to an investigational microbicide gel that could prevent transmission of HIV and genital herpes, its maker, Australia-based pharmaceutical company StarPharma, announced Jan. 10.
VivaGel incorporates nanotechnology to block the ability of HIV and herpes to bind to human cells, the mechanism by which people become infected with the viruses. In a safety study of 35 Australian women, VivaGel was found to have no harmful side effects. With FDA fast-tracking the vaginal gel, larger efficacy studies will be carried out this year, and eventually StarPharma will test the drug in a population-based study at a number of global centers, including sites in Africa and Asia, said Jackie Fairley, the company's COO. If the trials are successful, VivaGel could be ready for marketing by 2008.
Microbicides could afford protection against STDs from several hours up to days and prove to be an invaluable weapon against AIDS. Although the gel is being developed for use by women, the same technology could be used for men, Fairley said.
Topical microbicides give women a degree of control, said Anthony Fauci, director of National Institute of Allergy and Infectious Disease at the National Institutes of Health, which recently awarded StarPharma $20 million to speed the development of VivaGel. "They're important because of the relationship between the HIV pandemic and women's ability to protect themselves in societies that don't allow them that freedom," said Fauci. In some countries, women are subject to physical violence for insisting that their partner use a condom, and even in the United States, women who want to use a condom may face pressure not to, he noted.
United Press International
01.11.2006; Olga Pierce
Does a Choice of Condoms Impact Sexually Transmitted Infection Incidence? A Randomized, Controlled Trial
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.