Expired Study
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Aurora, Colorado 80045


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



Primary Contact:

Principal Investigator
Jennifer Kiser, PharmD
University of Colorado, Denver

Backup Contact:


Location Contact:

Aurora, Colorado 80045
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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