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Status
Completed
Phase
I
Principal Investigator(s)
Craig Hendrix, MD, Kristine Patterson, MD, Kenneth Mayer, MD, Adriana Andrade, MD, MPH
Objective
Describe the dose-proportionality and intra-individual variability of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) at steady-state in healthy human participants taking Truvada® (FTC 200mg/TDF 300 mg) under direct observation.
Prevention Option(s)
PrEP
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
One tablet orally weekly
Mode of Delivery
Tablet
Products
FTC
TDF/FTC (Truvada)
ARMs
Experimental
Description
One tablet orally twice weekly
Mode of Delivery
Tablet
Products
FTC
TDF/FTC (Truvada)
ARMs
Experimental
Description
Two tablets orally twice weekly
Products
FTC
TDF/FTC (Truvada)
ARMs
Experimental
Description
One tablet orally daily
Products
FTC
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
Trial Sponsors
HPTN
January 2011
October 2011
Enrollment
32
18
Years
44
Years
Population
Women
Men
Sites
Johns Hopkins University
Baltimore, Maryland
United States of America
University of North Carolina, Chapel Hill
United States of America