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MTN 034

Status
Ongoing
Phase
II
Principal Investigator(s)
Gonasagrie Nair, MBChB, MPH
Objective

The 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 May 9, 2021

Prevention Option(s)
Microbicides
PrEP
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Sequence 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 Delivery
Ring
Tablet
Products
Dapivirine Ring
TDF/FTC (Truvada)
ARMs
Experimental
Description
Experimental: 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 Delivery
Ring
Tablet
Products
Dapivirine Ring
TDF/FTC (Truvada)
ARMs
Experimental
Trial Sponsors
NIAID (DAIDS-ES: 12066), NICHD, NIMH, NIH, IPM
January 2019
October 2021
Enrollment
247
16
Years
21
Years
Population
Women
Sites

Emavundleni Desmond Tutu HIV Centre CRS

Cape Town
South Africa

Wits Reproductive Health and HIV Institute (Wits RHI)

Johannesburg
South Africa

Kisumu CRS

Kenya

UZ-UCSF HIV Prevention Trials Unit - Spilhaus

Harare
Zimbabwe

MU-JHU Research Collaboration CRS

Kampala
Uganda