Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03126370 · ClinicalTrials.gov registry record · Phase 4
Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT03126370 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 10 participants.
The verdict
NCT03126370, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will evaluate the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide (TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate \[TDF\]), and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to participate. The study will consist of five visits: a screening visit, three abbreviated 4-hour pharmacokinetic visits, and one end-of-study follow-up visit. Subjects will also be asked to use a Wisepill device, which will track medication adherence throughout the study.
Interventions
- DRUG TDF with a boosted protease inhibitor
- DRUG TAF with a boosted protease inhibitor
- DRUG TAF with a boosted protease inhibitor and LDV/SOF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-01-08 |
| Est. Completion | 2019-10-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03126370
The ClinicalTrials.gov registry entry for NCT03126370 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 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 3 interventions - of which TDF with a boosted protease inhibitor is the first listed.
NCT03126370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03126370 about?
NCT03126370 is a clinical study titled "Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)". This study will evaluate the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide (TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving tenofovir-based antiretroviral therapy (in...
What is the current status of trial NCT03126370?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2018-01-08. Estimated completion is 2019-10-01.
What interventions are being tested in trial NCT03126370?
The interventions under investigation include: TDF with a boosted protease inhibitor (DRUG), TAF with a boosted protease inhibitor (DRUG), TAF with a boosted protease inhibitor and LDV/SOF (DRUG).
Who is sponsoring clinical trial NCT03126370?
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.