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Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT02588287
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
10
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Blood draws for tenofovir PK, renal function
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tenofovir PK before and after SOF/LDV

Other: Blood draws for tenofovir PK, renal function

Outcome Measures

Primary Outcome Measures

  1. Change in area under the plasma concentration (AUC) of tenofovir [4 weeks]

    Compare tenofovir AUC0-24 before and after administration of SOF/LDV

Secondary Outcome Measures

  1. Change in Estimated Glomerular Filtration Rate (eGFR) [14 weeks]

    Compare eGFR calculated using Modification of Diet in Renal Disease (MDRD) equation before and after the addition of SOF/LDV.

  2. Change in concentrations of tenofovir-diphosphate [4 weeks]

    Compare concentrations of tenofovir-diphosphate in peripheral blood mononuclear cells and red blood cells before and after the addition of SOF/LDV

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • On tenofovir and a ritonavir-boosted PI for at least 30 days initiating HCV treatment with SOF/LDV

  • HCV RNA <48 copies/mL at most recent clinic visit

Exclusion Criteria:

  • eGFR < 60 ml/min

  • history of renal disease

  • Pregnant or planning pregnancy

  • Any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with study participation or the study outcomes

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Hospital Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

  • Principal Investigator: Jennifer Kiser, PharmD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02588287
Other Study ID Numbers:
  • 15-0123
  • UL1TR001082
First Posted:
Oct 27, 2015
Last Update Posted:
Aug 11, 2021
Last Verified:
Aug 1, 2021
Additional relevant MeSH terms:
Hepatitis C
Coinfection
HIV Infections
Tenofovir

Study Results

No Results Posted as of Aug 11, 2021