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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: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT03126370 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Compare plasma tenofovir AUC0-24 between TAF with boosted PI vs. TDF with boosted PI (Phase 2 vs. 1), and between TAF with boosted PI and LDV/SOF vs. TDF with boosted PI (Phase 3 vs. 1)
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 |
What the finished NCT03126370 record still lists
NCT03126370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which TDF with a boosted protease inhibitor is the first listed.
NCT03126370 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03126370's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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