Single Dose Truvada Study
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|ClinicalTrials.gov Identifier: NCT03719053|
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence HIV Prevention||Drug: Tenofovir||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Observed Dose Administration of Truvada® to Establish Single Dose Pharmacokinetic Standards in Healthy Individuals|
|Actual Study Start Date :||October 25, 2018|
|Actual Primary Completion Date :||June 30, 2020|
|Actual Study Completion Date :||June 30, 2020|
single oral dose of Truvada® (300 mg tenofovir disoproxil fumarate)
pre- and post-dosing measurements of TFV and TFV-DP in plasma and PBMCs.
Other Name: Truvada
- Plasma Tenofovir (TFV) concentration in ng/mL [ Time Frame: 24 hours ]
- Peripheral Blood Mononuclear Cells (PBMC) TFV diphosphate (TFV-DP) concentration in femtomole per million cells (fmol/10^6) [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719053
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Craig Hendrix||Johns Hopkins University|