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NCT02962739 · ClinicalTrials.gov registry record · Phase 1

The Cellular Pharmacology of F-TAF in Dried Blood Spots

A Phase 1 study, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 1
Development phase
38
Enrollment target

NCT02962739 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 38 participants.

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The verdict

NCT02962739, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 1
Development phase
38 participants
Enrollment target

Study Summary

Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide (F/TAF) works for treatment of chronic human immunodeficiency virus (HIV), or prevention of HIV acquisition. Methods to measure medication adherence to Tenofovir disoproxil fumarate (tenofovir DF, TDF), a similar but different prodrug of tenofovir, have been developed but cannot be extrapolated to F-TAF. By measuring F-TAF (the drug) and metabolites in the blood cells and dried blood spots, the study plans to see if these results predict adherence to taking the drug. The goal of this study is to vary the amount of F-TAF dosing and see if the drug levels in dried blood spots (DBS) change in a predictable way. This study will mimic different levels of adherence (33%, 67%, and 100% of daily dosing) using directly observed therapy (DOT) to establish the relationship between F-TAF in dried blood spots and adherence. Investigators will also measure drug in hair clippings to see if hair or DBS are a better predictor of adherence.

Interventions

  • DRUG emtricitabine 200 mg/tenofovir alafenamide 25mg

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2016-03
Est. Completion 2019-05-22
Phase Phase 1

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT02962739

The ClinicalTrials.gov registry entry for NCT02962739 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which emtricitabine 200 mg/tenofovir alafenamide 25mg is the first listed.

NCT02962739 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02962739 about?

NCT02962739 is a clinical study titled "The Cellular Pharmacology of F-TAF in Dried Blood Spots". Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide (F/TAF) works for treatment of chronic human immunodeficiency virus (HIV), or prevention of HIV acquisition. Methods to measure medication adherence to Tenofovir disoproxil fumarate (tenofovir DF, TDF), a si...

What is the current status of trial NCT02962739?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2016-03. Estimated completion is 2019-05-22.

What interventions are being tested in trial NCT02962739?

The interventions under investigation include: emtricitabine 200 mg/tenofovir alafenamide 25mg (DRUG).

Who is sponsoring clinical trial NCT02962739?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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