Medication Adherence Clinical Trial
Official title:
Single Observed Dose Administration of Truvada® to Establish Single Dose Pharmacokinetic Standards in Healthy Individuals
This study examines tenofovir (TFV) drug concentrations in adults one day after taking a single dose of Truvada® - a pill used to prevent and treat HIV infection. The results of this study will be used to improve the (efficacy/accuracy) of a white coat adherence (WCA) detection test - a blood test that can be used to indicate medication adherence. Participants will receive one dose of Truvada®, and provide 2 total samples of blood.
To establish the plasma and peripheral blood mononuclear cells (PBMC) concentrations of TFV
and TFV diphosphate (TFV-DP), respectively, following a single oral dose of Truvada® [300 mg
tenofovir disoproxil fumarate (TDF) in fixed dose combination with emtricitabine (FTC)], the
same formulation used for HIV pre-exposure prophylaxis (PrEP), and in prior benchmarking
adherence studies (HPTN 066). This will be compared to steady-state TFV and TFV-DP
concentrations to more robustly differentiate single dose concentrations from steady-state
concentrations.
This is part of a larger project to determine the frequency of white coat adherence in
several clinical studies where doses are not observed. For purposes of diagnosing WCA with
TDF, the investigators define WCA quantitatively as taking a single dose of TDF preceded by
no doses in the prior week. The investigators will compare TFV and TFV-DP concentrations
following an observed single oral dose of TDF/FTC to steady-state concentrations of TFV and
TFV-DP after daily dosing under observation.
The study plan involves a screening visit to assess eligibility, followed by two study
visits. Visit one involves pre-dose blood testing, followed by a single dose of Truvada.
Visit two occurs 24-hours after visit one, and involves collection of a final post-dose blood
sample. Blood will be assessed for tenofovir and tenofovir analyte concentrations.
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