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.
Protocol Title
Phase 2 Expanded Safety Study of Tenofovir Gel in Pregnancy
DAIDS Protocol ID
11839
Status
Withdrawn
Countries
Malawi
Uganda
United States
Zimbabwe
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)
Study Sites