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CONRAD A18-146

Status
Completed
Phase
I
Objective

The purpose of this Phase I study is to assess the safety, pharmacokinetics, and pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG).

Prevention Option(s)
Microbicides
Multipurpose Prevention Technologies
Study Design
Randomized
Arms and Assigned Interventions
Description
Post-dose sampling at 4 and 48 hours or at 24 and 72 hours, per randomization. 1 combination vaginal insert (20mg TAF/16mg EVG)
Mode of Delivery
Tablet
Products
Elvitegravir (EVG)
F/TAF
ARMs
Experimental
Trial Sponsors
CONRAD
December 2018
June 2019
Enrollment
16
18
Years
50
Years
Population
Women
Sites

Eastern Virginia Medical School

Norfolk, Virginia
United States of America