The purpose of this study is to test the safety and tolerability of a medication applied
vaginally twice daily in females versus placebo (inactive substance). Study participants will
include 60 women, ages 18-24, non-pregnant, previously sexually active, Human
Immunodeficiency Virus (HIV) negative and sexually transmitted infection (STI) free, in San
Francisco or Kisuma, 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. Participants may be involved in study related procedures for up to 55 days.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)