MTN 034 / IPM 045 / REACH
Status:Ongoing
Phase:II
Principal Investigator(s):Gonasagrie Nair, MBChB, MPH
Objective:A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female PopulationThe purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females. Last update September 23, 2022
Prevention Option(s):Microbicides, PrEP
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionSequence A: Dapivirine vaginal ring + FTC/TDF
Participants will receive one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks.
Mode of DeliveryRing, Tablet
ARMsExperimental
DescriptionExperimental: Sequence B: FTC/TDF + Dapivirine vaginal ring
Participants will receive one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks.
Mode of DeliveryRing, Tablet
ARMsExperimental
Official Code:
NCT03593655
Trial Sponsors:
IPM, NIAID (DAIDS-ES: 12066), NICHD, NIH, NIMH
Start Date
End Date
January 14, 2019
October 31, 2021
Enrollment:247
Age range:
16 Years ↔
21 Years
Population:Cisgender Women