Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women (MIP)
Status:Stopped Early
Phase:Open Label
Principal Investigator(s):Anandi Sheth, MD
Objective:This study seeks to understand the immune cells in the cervical fluid of in the blood and genital tract of HIV-negative healthy female volunteers and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine used in the treatment of HIV infection.
*Study was terminated as minimal efficacy of maraviroc alone was found in preliminary data analysis of another study*
Prevention Option(s):PrEP
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionWomen will be assigned at random Maraviroc 300 mg PO daily
Mode of DeliveryTablet
ARMsExperimental
DescriptionWomen will be assigned at random Truvada 1 tablet PO daily
Mode of DeliveryTablet
ARMsExperimental
Official Code:
NCT02333045
Trial Sponsors:
Emory University
Start Date
End Date
January 22, 2015
January 22, 2020
Enrollment:40
Age range:
18 Years ↔
44 Years
Population: