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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: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT02962739 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) respective to dosing regimens of 33%, 67%, 100% of daily dosing.
Interventions
- DRUG emtricitabine 200 mg/tenofovir alafenamide 25mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2016-03 |
| Est. Completion | 2019-05-22 |
| Phase | Phase 1 |
What the finished NCT02962739 record still lists
NCT02962739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which emtricitabine 200 mg/tenofovir alafenamide 25mg is the first listed.
NCT02962739 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02962739's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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