MTN-004
- Protocol Title
- Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGelTM) Applied Vaginally in Sexually Active Young Women
- DAIDS Protocol ID
- 10492
- Status
- Enrolling
- MTN-004 is a Phase I study evaluating the safety, acceptability and ease of use of the microbicide candidate VivaGel™ (SPL7013 Gel) in sexually active, HIV-negative women ages 18 to 24. Microbicides are substances designed to prevent the sexual transmission of HIV and other sexually transmitted infections when applied topically to the surface of the vagina. The study, which was launched in July of 2007, was paused in October 2007 and researchers are now making modifications to the protocol that will enhance the study’s ability to capture relevant safety data. The study will enroll 60 women at two sites and take approximately one year to complete. Results of the trial will help researchers determine if the product should be considered for further testing in a larger study, and eventually, in a trial to evaluate if use of the gel can prevent sexual transmission of HIV in young women.