Details
- Protocol Title
- Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel®) Applied Vaginally in Sexually Active Young Women
- DAIDS Protocol ID
- 10492
- Status
- Closed to accrual
Description
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. The study will enroll approximately 61 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. The study is being conducted in collaboration with the Adolescent Medicine Trials Network for HIV/AIDS Interventions of the U.S. Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Other Study Info
Sponsors:
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institutes of Health
Co-Sponsor:
Starpharma Pty Ltd
Study design:
Phase 1, two arm, two site, randomized, double blind, placebo-controlled trial comparing VivaGel® Gel, VivaGel® placebo, or HEC placebo applied vaginally twice daily for 14 days