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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 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. The trial reports 1 study location across 1 state.

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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).

Interventions

  • OTHER Blood draws for tenofovir PK, renal function

Study Locations (1)

Colorado

  • University of Colorado Hospital - Aurora

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2015-11
Est. Completion 2016-09
Phase NA

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT02588287

The ClinicalTrials.gov registry entry for NCT02588287 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 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 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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

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.