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CONRAD 137

Status
Completed
Phase
I
Objective

This multi-center Phase I study is designed to characterize the PK and PD of F/TAF oral tablets to assess systemic and genital tract bioavailability in healthy women. The oral tablets to be used in the study are F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300 mg, Truvada). 

Prevention Option(s)
PrEP
Study Design
Randomized
Arms and Assigned Interventions
Description
Emtricitabine (FTC) + Tenofovir Alafenamide (TAF) (200/10 mg)
Mode of Delivery
Tablet
Products
F/TAF
ARMs
Experimental
Description
Emtricitabine (FTC) + Tenofovir Alafenamide (TAF) (200/25 mg)
Mode of Delivery
Tablet
Products
F/TAF
ARMs
Experimental
Description
The active comparator arm will recevie Emtricitabine (FTC) + Tenofovir Disoproxil Fumarate (TDF) (200/300 mg)
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Placebo Comparator
Official Code
NCT02904369
October 2016
October 2017
Enrollment
72
18
Years
50
Years
Population
Women