CONRAD A18-146

Status:Completed
Phase:I
Principal Investigator(s):
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). This product is supported by the MATRIX project (Product page)Last updated September 27, 2022
Prevention Option(s):Microbicides, MPTs
Study Design:Randomized
Arms and Assigned Interventions
DescriptionPost-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 DeliveryTablet
ARMsExperimental
Official Code: NCT03762772
Trial Sponsors: CONRAD
Start Date
End Date
December 11, 2018
March 20, 2019
Enrollment:16
Age range: 18 Years ↔ 50 Years
Population:Cisgender Women