An Open-Label Study to Explore the Clinical Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant in HIV-HCV infected patients

niversità di Modena e ReggioEmilia0 sites15 target enrollmentJuly 8, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Individuals with HIV-HCV co-infection and end-stage liver disease, with an indication for liver transplantation
Sponsor: niversità di Modena e ReggioEmilia
Enrollment: 15
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

July 8, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversità di Modena e ReggioEmilia

•1\.Males or females at least 18 years old at Screening. Subjects or their heterosexual partner(s) must either be of non\-childbearing potential or they must use effective contraception from 2 weeks before the initiation of therapy until 6 months after the last dose of study medication.
•2\.HIV\-HCV Co\-infection documented with HIV\-Ab and HCV RNA positivity
•2\.1Chronic HCV\-infection, any genotypes, documented by at least one measurement of serum HCV RNA above the lower limit of quantification (LLoQ) measured during Screening
•2\.2 Chronic HIV infection undergoing antiretroviral therapy for at least 6 month with HIV Viral Load \< 40 copies/ml
•3\. End stage Liver disease (ESLD) or HCC secondary to HCV meeting the MILAN criteria with a MELD between 15 and 35 and waiting list for OLT
•4\. Subjects must be naïve to treatment with NS5B polymerase inhibitors for chronic HCV infection.
•5\. A body mass index (BMI) of \>\=18 kg/m2\.
•6\. Able to effectively communicate with the Investigator and other center personnel. Willing to give written informed consent and comply with the study restrictions and requirements.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\. Any transplant patient who has agreed to a liver transplant from a live donor.
•2\. Patients requiring planned induction therapy with biologics post\-transplantation or with a post\-transplantation immunosuppressive regimen not consistent with:
•o Solumedrol/Prednisone
•o Tacrolimus (maintaining a serum level of 5\-12 ng/mL)
•3\. Chronic medical conditions, especially if treated with medications (such as hypertension), must be stable at the time of screening and first dose.
•4\. Clinically significant ECG findings at screening, screening QTc \= 500 ms (cirrhotic), or a personal or family history of Torsades de pointes
•5\. History of major organ transplantation with an existing functional graft.
•6\. Active substance abuse which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study.
•7\. Abnormal hematological and biochemical parameters, including:
•a.neutrophil count \<1000 cells/mm3