Starpharma Holdings Limited today announced the commencement in the U.S. of a trial to assess the safety and acceptability of SPL7013 Gel (VivaGel) in sexually active young women.
The Microbicide Trials Network (MTN) is leading the study, funded by the U.S. National Institutes of Health (NIH), in which VivaGel will be tested for the first time in sexually active young women to determine its safety, acceptability and ease of use. VivaGel is being developed as a vaginal microbicide for the prevention of HIV and genital herpes.
The expanded safety study is being conducted at the University of South Florida in Tampa, Florida, and the University of Puerto Rico in San Juan, Puerto Rico, through a collaboration between the MTN (an HIV/AIDS clinical trials network established by the National Institute of Allergy and Infectious Diseases, NIH), the Adolescent Medicine Trials Network for HIV/AIDS Interventions (of the National Institute of Child Health and Human Development, NIH), and Starpharma.
Nearly 50 percent of people infected with HIV/AIDS today are women and most of them become infected through sexual intercourse with male partners. Women under the age of 25 are particularly at risk of infection.
"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. This study, in addition to the usual safety data, will collect valuable information regarding the product’s use and acceptability in the consumer setting," said Dr Jackie Fairley, Chief Executive Officer of Starpharma.
"The data from this trial will provide information of value to the development of VivaGel for all indications, including preventing the spread of genital herpes," added Dr Fairley.