deLIVER: Direct Acting Antiviral Effects on the Liver

Completed · Phase 4

Conditions studied: HCV Coinfection, Liver Disease, HIV

In brief

Open-label, partially-randomized plasma and liver sampling study to assess hepatitis C virus (HCV) kinetics during treatment with two (Sofosbuvir/Velpatasvir) or three (Sofosbuvir/Velpatasvir/Voxilaprevir) direct acting antivirals (DAAs)

Key facts

Study ID

NCT02938013

Run by

Johns Hopkins University

People needed

15

Starts

2017-01-01

Expected to finish

2020-09-30

Last updated by the study team

2022-02-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
• Breastfeeding.
• Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
• Acute or serious illness requiring systemic treatment and/or hospitalization within 42 days prior to study entry.
• Active hepatitis B infection (positive HBsAg) within 42 days prior to study entry.
• History of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry.
• Any cause of liver disease other than chronic HCV infection, including but not limited to the following:
• Hemochromatosis
• Alpha-1 antitrypsin deficiency
• Wilson's disease
• Autoimmune hepatitis
• Alcoholic liver disease
• Drug-related liver disease
• Uncontrolled or active depression or other psychiatric disorder within 24 weeks prior to study entry that in the opinion of the investigator might preclude adherence to study requirements.
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• Serious illness including uncontrolled seizure disorders, active coronary artery disease within 24 weeks prior to study entry, or other chronic medical conditions that in the opinion of the investigator might preclude completion of the protocol.
• Presence of active or acute AIDS-defining opportunistic infections within 12 weeks prior to study entry.
• Active or history of malignancy within 2 years prior to study entry other than basal cell carcinoma of the skin and/or cutaneous Kaposi's sarcoma (KS) and/or cervical or anal dysplasia or carcinoma in situ.
• Infection with any HCV genotype other than genotype 1a, or mixed genotype infection any time prior to study entry.
• History of major organ transplantation with an existing functional graft any time prior to study entry.
• History of acquired or hereditary bleeding disorder (e.g., hemophilia, warfarin use) or any other cause of or tendency toward excessive bleeding time prior to study entry.
• Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug 17. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 18. Planning to take any of the following medications or supplements from Day -7 to the end of treatment:
• Proton pump inhibitors (patients may switch to H2 blockers up to Day -7)
• Inducers of P-gp (including, but not limited to, dexamethasone, morphine, ritonavir, saquinavir, tipranavir)
• Moderate to potent inducers of CYP2B6, CYP2C8, or CYP3A4 (including, but not limited to, efavirenz, etavirine, modafinil, rifampin, St. John's Wort, carbamazepine, phenytoin) 19. History of taking any dose of amiodarone within 6 months (180 days) of Day 0

Where it is running

• Johns Hopkins Hospital : The John G. Bartlett Specialty Practice — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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