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
DescriptionSubjects will take one Truvada tablet orally for seven consecutive days.
Mode of DeliveryTablet
ARMsExperimental
DescriptionSubjects will insert 5 mL of lubricant in rectum and take one Truvada tablet orally for seven consecutive days
Mode of DeliveryGel, Tablet
ARMsExperimental
Official Code:
NCT02401230
Trial Sponsors:
CDC, Emory University
Start Date
End Date
March 5, 2015
January 16, 2017
Enrollment:60
Age range:
18 Years ↔
49 Years
Population:Cisgender Men, Gay and Bisexual Men Who Have Sex with Men