Aug 18 2008
Starpharma Holdings Limited today announced the start of its next clinical trial of VivaGel®. The study will measure the level of antiviral activity retained by VivaGel® after vaginal administration. Assessment will be by laboratory assay of vaginal samples collected up to 24 hours after VivaGel® application. The study in 12 women will determine the timescale over which VivaGel® retains activity against HIV and HSV-2 (genital herpes).
"The value of this short trial is that it provides a potential surrogate for antiviral efficacy of VivaGel® in humans ahead of Phase 3 studies,” said Dr Jackie Fairley, Chief Executive Officer of Starpharma. “It will also give an indication of just how long before sex you could apply VivaGel® to prevent infection,” added Dr Fairley.
The study is being conducted at the Centre for Clinical Studies in Melbourne and is funded by the U.S. National Institutes of Health (NIH).*
Additional details of the study are included in Appendix 1 to this announcement. VivaGel® is being developed as a vaginal microbicide for the prevention of HIV and HSV-2. Other applications of VivaGel® are also under assessment, including prevention of human papillomavirus (HPV), contraception and treatment of bacterial vaginosis (BV)