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PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV

Status
Completed
Phase
IV
Principal Investigator(s)
Colleen Kelley, MD/MPH
Objective

The purpose of this study is to determine whether the use of rectal lubricants can affect how well the medication, Truvada, will work to prevent infection with HIV when someone is exposed to HIV in the rectum.

Prevention Option(s)
PrEP
Study Design
Randomized
Arms and Assigned Interventions
Description
Subjects will insert 5 mL of over the counter sexual lubricant in rectum for seven consecutive days.
Mode of Delivery
Gel
ARMs
Experimental
Description
Subjects will take one Truvada tablet orally for seven consecutive days.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Subjects will insert 5 mL of lubricant in rectum and take one Truvada tablet orally for seven consecutive days
Mode of Delivery
Gel
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
NCT02401230
Trial Sponsors
Emory University, Centers for Disease Control and Prevention
March 2015
January 2017
Enrollment
60
18
Years
49
Years
Population
Men
MSM
Sites

Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia
United States of America