U.S. Universities Begin Trial on Microbicide Developed by Australian Pharmaceutical Company
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). FDA in January 2006 granted an accelerated review of VivaGel. The agency also announced that it will become more involved in further human trials of the gel. VivaGel did not cause any harmful side effects in trials of 35 women in Australia and also was effective in preventing the 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 Interventions and Starpharma. Starpharma CEO Jackie Fairley said the goal of the trial is to determine the safety and usability of the gel. "We have already conducted clinical trials on the safety of VivaGel in sexually inactive women and men, but this is the first time the product will be used in sexually active young women, one of our target populations," Fairley said. She added that the data from the trial will "provide information 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).