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

Not Applicable

Completed

• Conditions: Hepatitis C and HIV Coinfection
• Interventions: Other: Blood draws for tenofovir PK, renal function

• Registration Number: NCT02588287
• Lead Sponsor: University of Colorado, Denver

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Study Start: 2015-11
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tenofovir PK before and after SOF/LDV	Blood draws for tenofovir PK, renal function	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States