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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Hepatitis C and HIV Coinfection

Treatments: Other: Blood draws for tenofovir PK, renal function

Study type: Interventional

Funder types: Other

Identifiers

NCT02588287

15-0123

UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Tenofovir PK before and after SOF/LDV

Experimental group

Treatment:

Other: Blood draws for tenofovir PK, renal function