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

Completed · Not applicable

Conditions studied: Hepatitis C and HIV Coinfection

In brief

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).

Key facts

Study ID

NCT02588287

Run by

University of Colorado, Denver

People needed

14

Starts

2015-11-01

Expected to finish

2016-09-01

Last updated by the study team

2021-08-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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