U.S. NIH funded trial of VivaGel in sexually active young women commences

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.

The study will enroll 40 sexually active, HIV-negative women aged 18 to 24 years. Participants will be randomly assigned to one of two study groups. One group will apply VivaGel twice a day for two weeks and the other will apply a placebo gel.

The safety of VivaGel compared with the placebo will be assessed by laboratory tests and clinical examination of the participants.

Product acceptability assessments in the trial will provide very useful and product-specific preliminary information to add to the growing body of data supporting the attractiveness of topical gel microbicides in this consumer group.

The importance of topical microbicides is highlighted by statistics from UNAIDS and the U.S. Centers for Disease Control and Prevention that show 48 percent of the 39.5 million people living with HIV/AIDS are women, and among 15- to 24- year-olds with HIV, females account for 60 percent. In the U.S., 43 percent of AIDS cases in the 13- to 19-year-old age group are female.