FACTS 001

Status:Completed
Phase:III
Principal Investigator(s):Cynthia N Gama, MBCHB; Linda-Gail Bekker, MBChB, DCH, DTMH; Glenda Gray, MBBCH, FCPaeds; Thesla Palanee, PhD; Sydney L Sibiya, MBChB; atsontso Paul Mathebula, MBChB; Salome Charalambous, MBBCh, MSc; Khatija Ahmed, MBChB, FCPath, MMed; W.L. Brumskine, Ph.D
Objective:To assess the safety and effectiveness of intravaginal 1% tenofovir gel in prevention HIV-1 injection and HSV-2 infection in sexually active young women.
Prevention Option(s):Microbicides
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionFirst dose: intravaginally up to 12 hours before each act of vaginal intercourse Second dose: within 12 hours after coitus No more than 2 applications within a 24 hour period.
Mode of DeliveryGel
ARMsExperimental
DescriptionFIrst dose: intravaginally up to 12 hours before each act of vaginal intercourse Second dose: within 12 hours after coitus No more than 2 applications within a 24 hour period.
Mode of DeliveryGel
ARMsPlacebo Comparator
Results: Study does not confirm pericoital tenofovir gel effectiveness
Official Code: NCT01386294
Start Date
End Date
October 31, 2011
December 31, 2014
Enrollment:1,700
Age range: 18 Years ↔ 40 Years
Population: