Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
University of Colorado, Denver


Information provided by (Responsible Party)
University of Colorado, Denver
ClinicalTrials.gov Identifier
NCT02588287

First received: October 26, 2015
Last updated: January 14, 2020
Last Verified: January 2020
History of Changes
Purpose

Purpose

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 Intervention
Hepatitis C and HIV Coinfection

Other : Blood draws for tenofovir PK, renal function

Study Type: Interventional
Study Design: 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

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures

  • Change in area under the plasma concentration (AUC) of tenofovir [ Time Frame: 4 weeks ]
    Compare tenofovir AUC0-24 before and after administration of SOF/LDV
Secondary Outcome Measures:
  • Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 14 weeks ]
    Compare eGFR calculated using Modification of Diet in Renal Disease (MDRD) equation before and after the addition of SOF/LDV.
  • Change in concentrations of tenofovir-diphosphate [ Time Frame: 4 weeks ]
    Compare concentrations of tenofovir-diphosphate in peripheral blood mononuclear cells and red blood cells before and after the addition of SOF/LDV

Estimated Enrollment: 15
Study Start Date: November 2015
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Tenofovir PK before and after SOF/LDV

Other: Blood draws for tenofovir PK, renal function
Eligibility

Eligibility

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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02588287

Locations

United States, Colorado
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
More Information

More Information


Responsible Party: University of Colorado, Denver  
ClinicalTrials.gov Identifier: NCT02588287   History of Changes  
Other Study ID Numbers: 15-0123  
  UL1TR001082  
Study First Received: October 26, 2015  
Last Updated: January 14, 2020  

Additional relevant MeSH terms:
Coinfection
Hepatitis C
HIV Infections
Tenofovir
Sofosbuvir
Ledipasvir

ClinicalTrials.gov processed this data on April 08, 2020
This information is provided by ClinicalTrials.gov.