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



Status:Active, not recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:1/16/2019
Start Date:November 2015
End Date:June 2019

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Trial Summary
Trial Overview
Inclusion Criteria
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).


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
We found this trial at
1
site
University of Colorado Hospital
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Phone: 303-724-6131
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