The Cellular Pharmacology of F-TAF in Dried Blood Spots
Status:
Completed
Trial end date:
2019-05-22
Target enrollment:
Participant gender:
Summary
Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide
(F/TAF) works for treatment of chronic human immunodeficiency virus (HIV), or prevention of
HIV acquisition. Methods to measure medication adherence to Tenofovir disoproxil fumarate
(tenofovir DF, TDF), a similar but different prodrug of tenofovir, have been developed but
cannot be extrapolated to F-TAF. By measuring F-TAF (the drug) and metabolites in the blood
cells and dried blood spots, the study plans to see if these results predict adherence to
taking the drug. The goal of this study is to vary the amount of F-TAF dosing and see if the
drug levels in dried blood spots (DBS) change in a predictable way. This study will mimic
different levels of adherence (33%, 67%, and 100% of daily dosing) using directly observed
therapy (DOT) to establish the relationship between F-TAF in dried blood spots and adherence.
Investigators will also measure drug in hair clippings to see if hair or DBS are a better
predictor of adherence.