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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
Randomized
Open label
Arms and Assigned Interventions
Description
Women will be assigned at random Maraviroc 300 mg PO daily
Mode of Delivery
Tablet
Products
Maraviroc
ARMs
Experimental
Description
Women will be assigned at random Truvada 1 tablet PO daily
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Trial Sponsors
Emory University
January 2015
January 2020
Enrollment
40
18
Years
44
Years
Sites

Grady Infectious Diseases Clinic (Ponce Clinic)

Atlanta, Georgia
United States of America

Grady Memorial Hospital

Atlanta, Georgia
United States of America