Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)
Status:
Completed
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the
pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide
(TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving
tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate [TDF]),
and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to
participate.
The study will consist of five visits: a screening visit, three abbreviated 4-hour
pharmacokinetic visits, and one end-of-study follow-up visit.
Subjects will also be asked to use a Wisepill device, which will track medication adherence
throughout the study.
Phase:
Phase 4
Details
Lead Sponsor:
University of Colorado, Denver
Treatments:
Emtricitabine Emtricitabine tenofovir alafenamide HIV Protease Inhibitors Ledipasvir Ledipasvir, sofosbuvir drug combination Protease Inhibitors Sofosbuvir Tenofovir