Microbicide Trials Network

MTN-019

Details

Protocol Title: 
Phase 2 Expanded Safety Study of Tenofovir Gel in Pregnancy
DAIDS Protocol ID: 
11839
Status: 
Withdrawn

Protocol Chair(s)

Richard Beigi (Protocol Co-Chair)
Bonus Makanani (Protocol Co-Chair)

Description

Recent success of proof of concept for an antiretroviral (ARV)-based microbicide has shown that ARVs used as a prevention strategy have the potential to transform how the world responds to the HIV/AIDS pandemic. With the potential for ARV use en masse for prevention, establishing the safety profile of these products among reproductive-aged women is critical. MTN-019 will be the first study of planned repeat dosing of 1% tenofovir gel for a 4-week duration among pregnant women at different gestational ages, including those in the second trimester of pregnancy. These critical safety data from pregnant women in the U.S. and in African countries will further inform the extensive safety and efficacy trial data anticipated in upcoming years.

Other Study Info

Sponsors:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US National Institute of Child Health and Human Development

US National Institute of Mental Health

US National Institutes of Health

Study Design:

Double-blinded, multi-site, two-arm, randomized, placebo-controlled trial of daily vaginal use of 1% tenofovir gel vs. Universal Placebo gel with onset of 28-day dosing period to occur within the following gestational age ranges: 

Group 1: 36 0/7 weeks – 37 6/7 weeks (114 women)

Group 2: 28 0/7 weeks – 32 6/7 weeks (90 women)

Group 3: 20 0/7 weeks – 24 6/7 weeks (90 women)

Group 4: 12 0/7 weeks – 16 6/7 weeks (90 women)