An Expanded Phase I Randomized Placebo Controlled Trial of the Safety and Tolerability of 3% w/w SPL7013 Gel (VivaGel™) in Healthy Young Women When Administered Twice Daily for 14 Days
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Protocol Status: Closed to Enrollment
Protocol Title: An Expanded Phase I Randomized Placebo Controlled Trial of the Safety and Tolerability of 3% w/w SPL7013 Gel (VivaGel™) in Healthy Young Women When Administered Twice Daily for 14 Days Study: The purpose of this study is to test the safety and tolerability of a medication applied vaginally twice daily in females. Study participants will include 60 women, ages 18-24, non-pregnant, previously sexually active, HIV negative and sexually transmitted infection (STI) free, in San Francisco or Kisumu, Kenya. Each study participant will be followed for 14 days of product use and an additional 7 days for safety assessments. Study procedures will include a physical exam with a pap smear, urine testing, blood sample testing, and a colposcopy (exam of the vagina and cervix using a lighted magnifying instrument). Information learned from this study may help to develop a safe and effective medication that could prevent herpes simplex virus and HIV. Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study Population: Ages Eligible for Study: 18 Years to 24 Years Study Duration: Each study participant will be followed for 14 days of product use and an additional 7 days for safety assessments (21 days total). Primary Study Objective: to determine the safety and tolerability of VivaGel™ applied vaginally twice daily for 14 days in HIV negative and STI-free young women Study Sites: University of California (UCSF), San Francisco & Kenya Medical Research Institute (KEMRI) |
