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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02588287

Enrollment

Registered

2015-10-27

Start date

2015-11-30

Completion date

2016-09-30

Last updated

2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C and HIV Coinfection

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).

Interventions

OTHERBlood draws for tenofovir PK, renal function

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in area under the plasma concentration (AUC) of tenofovir	4 weeks	Compare tenofovir AUC0-24 before and after administration of SOF/LDV

Secondary

Measure	Time frame	Description
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.
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026