Clinical trial NCT02588287: Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
Official title: Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C and HIV Coinfection
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


Eligibility criteria: 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 outcomes:
measure: Change in area under the plasma concentration (AUC) of tenofovir
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: 14 weeks
measure: Change in concentrations of tenofovir-diphosphate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer Kiser, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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