DD-PrEP: Pharmacokinetic Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
Johns Hopkins University
Summary
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.
Description
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 t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * ≥18 years of age, inclusive on the date of screening * Provides written informed consent for the study * Good general health, as determined by medical history, physical examination, vital signs, screening laboratory tests * Non-reactive HIV test results within four weeks of enrollment * An estimated glomerular filtration rate (eGFR) of ≥ 70 mL/min/1.73 m2 via the CKD-EPI 2021 eGFRCr equation * Agrees to use condoms for all sexual events during study participation * Willing to abstain from oral PrEP use outside of study products for the duration of the study Exclusion Cr…
Interventions
- Drugtenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg
One-time dose of two F/TAF tablets
Location
- Johns Hopkins University School of MedicineBaltimore, Maryland