The goal of this study is to evaluate the pharmacokinetics of a one-time dosing of two F/TAF tablets over a 14-day period.
HIV prevention using oral pre-exposure prophylaxis (PrEP) with tenofovir-containing regimens is a promising strategy to reduce the incidence of HIV infection. The study participants will receive a double dose \[2 tablets\] of Descovy (tenofovir alafenamide \[TAF\] 25 mg/emtricitabine \[FTC\] 200mg; F/TAF) and be followed over the course of 14 days. Intensive pharmacokinetic (PK) will occur right after dose administration, and become sparser over the next 14 days. Understanding the PK of TAF, tenofovir (TFV), and FTC and the intracellular metabolites could be used to assess the protective and therapeutic plausibility of alternate, less frequent dosing regimens for PrEP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
One-time dose of two F/TAF tablets
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
RECRUITINGIntracellular tenofovir-diphosphate concentrations (fmol/10^6)
Time frame: 168 hours
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