Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03719053
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 1
Start date October 25, 2018
Completion date June 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT04709640 - Pilot Study to Improve Medication Management in Older Adults N/A
Completed NCT03257579 - Myocardial Infarction Prescription Duration Adherence Study N/A
Completed NCT05376397 - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) N/A
Withdrawn NCT03427008 - A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Kidney Transplant Recipients N/A
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Withdrawn NCT03292393 - Social Norms and Antihypertensive Medication Adherence N/A
Completed NCT02823795 - The Supporting Patient Activation in Transition to Home Intervention N/A
Not yet recruiting NCT02876848 - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study) N/A
Completed NCT02914730 - Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections
Completed NCT02066935 - Non-adherence to Immunosuppressives in Kidney Transplantation in Brazil Multicenter Study
Completed NCT02797262 - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System N/A
Completed NCT01934608 - The Effect of Synching Prescription Refills on Adherence N/A
Completed NCT01770314 - Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication. Phase 2
Completed NCT01741311 - Secondary HIV Prevention and Adherence Among HIV-infected Drug Users N/A
Recruiting NCT01105104 - An Enhanced Medication Monitoring Program Phase 1
Completed NCT01859273 - Adherence Enhancement for Renal Transplant Patients N/A
Withdrawn NCT01430702 - Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults N/A
Completed NCT01118208 - Blister Packaging Medication to Increase Treatment Adherence and Clinical Response N/A
Completed NCT00848224 - Improving Adherence to Pharmacological Treatment N/A
Completed NCT06034301 - Pill Bottle vs Reminder App N/A