CONRAD 137
Status:Completed
Phase:I
Principal Investigator(s):
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
DescriptionEmtricitabine (FTC) + Tenofovir Alafenamide (TAF) (200/10 mg)
Mode of DeliveryTablet
ARMsExperimental
DescriptionEmtricitabine (FTC) + Tenofovir Alafenamide (TAF) (200/25 mg)
Mode of DeliveryTablet
ARMsExperimental
DescriptionThe active comparator arm will recevie Emtricitabine (FTC) + Tenofovir Disoproxil Fumarate (TDF) (200/300 mg)
Mode of DeliveryTablet
ARMsPlacebo Comparator
Official Code:
NCT02904369
Start Date
End Date
October 6, 2016
October 5, 2017
Enrollment:72
Age range:
18 Years ↔
50 Years
Population:Cisgender Women