US Universities Begin Trial On Microbicide VivaGel
The University of South Florida and University of Puerto Rico have commenced a two-week clinical trial to test the microbicide VivaGel, officials with the Australian pharmaceutical company Starpharma, which is developing the product, announced on Tuesday, the AAP/Sydney Morning Herald reports (AAP/Sydney Morning Herald, 7/10). FDAin January 2006 granted an accelerated review of VivaGel. The agencyalso announced that it will become more involved in further humantrials of the gel.
VivaGel did not cause any harmful side effects intrials of 35 women in Australia and also was effective in preventingthe spread of genital herpes (Kaiser Daily HIV/AIDS Report, 1/10/06). The trial, which is funded by NIH, involves 40 sexually active, HIV-negative women between ages 18 and 24 (AAP/Sydney Morning Herald, 7/10).
The Microbicide Trials Network is leading the study in collaboration with NIH's Adolescent Medicine Trials Network for HIV/AIDS Interventionsand Starpharma. Starpharma CEO Jackie Fairley said the goal of thetrial is to determine the safety and usability of the gel. "We havealready conducted clinical trials on the safety of VivaGel in sexuallyinactive women and men, but this is the first time the product will beused in sexually active young women, one of our target populations,"Fairley said.
She added that the data from the trial will "provideinformation of value to the development of VivaGel for all indications,including preventing the spread of genital herpes" (Starpharma release, 7/10). Statistics show that 60% of HIV-positive women in the U.S. are between ages 15 and 24, according to the company (AAP/Sydney Morning Herald, 7/10).
Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyHIV/AIDS Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . TheKaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service ofThe Henry J. Kaiser Family Foundation.