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NCT02588287 · ClinicalTrials.gov registry record · NA
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
A NA study of Hepatitis C and HIV Coinfection, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02588287: Completed NA study of Hepatitis C and HIV Coinfection, sponsored by University of Colorado, Denver.
NCT02588287 is a NA study of Hepatitis C and HIV Coinfection that has completed, run by University of Colorado, Denver. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02588287, a NA study of Hepatitis C and HIV Coinfection, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV PI/r) and initiating SOF/LDV treatment for Hepatitis C virus (HCV) will be invited to participate. The study consists of three visits: a screening visit and two abbreviated 4-hour pharmacokinetic visits (one before initiating SOF/LDV and a second approximately 4 weeks after initiating SOF/LDV).
Primary Outcome
Compare tenofovir AUC0-24 before and after administration of SOF/LDV
Conditions Studied
Interventions
- OTHER Blood draws for tenofovir PK, renal function
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-09 |
| Phase | NA |
What the finished NCT02588287 record still lists
NCT02588287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hepatitis C and HIV Coinfection appearing as the primary indexed condition, and to 1 intervention - of which Blood draws for tenofovir PK, renal function is the first listed.
NCT02588287 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT02588287 about?
NCT02588287 is a clinical study titled "Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir". This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV PI/r) and initiating SOF/LDV treatment f...
What is the current status of trial NCT02588287?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2015-11. Estimated completion is 2016-09.
What conditions does trial NCT02588287 study?
This clinical trial studies the following conditions: Hepatitis C and HIV Coinfection.
What interventions are being tested in trial NCT02588287?
The interventions under investigation include: Blood draws for tenofovir PK, renal function (OTHER).
Who is sponsoring clinical trial NCT02588287?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02588287 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02588287's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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