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Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02460133
Recruitment Status : Active, not recruiting
First Posted : June 2, 2015
Last Update Posted : October 8, 2019
PEI Provincial Correction Centre
Information provided by (Responsible Party):
Lisa Barrett, Nova Scotia Health Authority

Brief Summary:
This pilot study is crucial to determining whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. It will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: Paritaprevir Drug: Ritonavir Drug: Dasabuvir Drug: Ombitasvir Drug: Ribavirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment: A Pilot Project
Study Start Date : July 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
HCV Genotype 1, with and without cirrhosis Drug: Paritaprevir
Drug: Ritonavir
Drug: Dasabuvir
Drug: Ombitasvir
Drug: Ribavirin
In genotype 1b individuals without cirrhosis, treatment will NOT include ribavirin.

Primary Outcome Measures :
  1. Re-infection rate in individuals treated with DAA therapy [ Time Frame: 1 year following treatment. ]
    This will require HCV quasispecies determination at baseline and in potentially re-infected individuals. Re-infection will require demonstration of HCV RNA above level of detection after SVR12 with a phyogenetically distinct HCV species.

Secondary Outcome Measures :
  1. Percentage of subjects with sustained virologic response at 12 weeks post treatment [ Time Frame: 12 Weeks post treatment ]
  2. Change in fibrosis measured by transient elastography [ Time Frame: From day 0 to the end of follow-up ]
  3. Global and HCV-specific T cell function before and after treatment with DAA therapy. [ Time Frame: From day 0 to end of follow-up ]
  4. Global and HCV-specific B cell function before and after treatment with DAA therapy. [ Time Frame: From day 0 to end of follow-up ]
  5. Global and HCV-specific NK cell function before and after treatment with DAA therapy. [ Time Frame: From day 0 to end of follow-up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • An offender at the PEI Provincial Correction Centre during the enrollment time
  • Male, 18 -70 years of age, inclusive, at time of screening
  • Chronic HCV genotype 1 infection
  • HCV infection, as demonstrated by positive HCV immunosorbant assay and detectable HCV viral load
  • No evidence of decompensated liver disease (refractory ascites, variceal bleed within 1 year, active hepatic encephalopathy or Child-Pugh score greater than 6)
  • HIV negative
  • Males must be abstinent from sexual intercourse, surgically sterile or agree to practice two effective forms of birth control from those listed below, throughout the course of the study, starting with Study Day 1 and for 7 months after the last dose of study drug (or per local RBV label):

    • Partner(s) using an IUD (intrauterine device),
    • Partner(s) using oral, injected, or implanted methods of hormonal contraceptives,
    • Subject and/or partner(s) using condoms, contraceptive sponge, or diaphragm with spermicidal jellies or creams.
  • Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements
  • Must voluntarily sign and date an informed consent form, approved by a Research Ethics Board prior to the initiation of any screening or study specific procedures

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any drug
  • Positive test result at screening for Hepatitis B surface antigen
  • Prior therapy with direct acting antivirals for the treatment of HCV
  • Evidence of decompensated liver disease (current or past refractory ascites, variceal bleed within 1 year, active hepatic encephalopathy)
  • HIV positive screening test
  • Unwilling to follow up for 48 weeks after treatment completion
  • Use of any herbal supplements (including milk thistle) within 2 weeks or 10 half-lives of the respective supplement, whichever is longer, prior to the first dose of study drug
  • HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
  • Use of any medications contraindicated for use with the study regimen
  • Clinically significant abnormalities, other than HCV-infection, based upon the results of a medical history, physical examination, vital signs, and laboratory profile that make the subject an unsuitable candidate for this study in the opinion of the investigator
  • Serum Alpha-Fetoprotein (AFP) > 200 ng/mL at screening
  • 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
    • Nonalcoholic steatohepatitis
    • Drug-related liver disease
  • Screening laboratory analyses showing any of the following abnormal laboratory results:

    • ALT > 5 × upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) > 5 × ULN
    • Calculated creatinine clearance (using Cockcroft-Gault method) < 60 mL/min
    • Albumin 25 g/L
    • Prothrombin time/International normalized ratio (INR) > 2.3.
    • Hemoglobin < LLN
    • Platelets < 60,000 cells per mm3
    • Absolute neutrophil count (ANC) < 1500 cells/μL
    • Total bilirubin ≥ 51 umol/L
  • History of solid organ transplantation.
  • Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 6 weeks prior to study drug administration.
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive paritaprevir, dasabuvir, ombitasvir, ritonavir and/or RBV.
  • Current enrollment in another clinical study, prior enrollment in this study, or previous exposure to paritaprevir, ombitasvir, or dasabuvir. Concurrent participation in a non-interventional, epidemiologic or registry trials may be permitted with approval of the principal investigator.
  • The use of colony stimulating factors, such as granulocyte colony stimulating factor (GCSF) or erythropoietin within 2 months of the screening period.
  • Uncontrolled clinically significant cardiac, respiratory (except mild asthma), hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness, which is unrelated to the hepatic disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02460133

Sponsors and Collaborators
Lisa Barrett
PEI Provincial Correction Centre
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Principal Investigator: Lisa Barrett, MD PhD FRCPC Department of Medicine, Division of Infectious Diseases, Nova Scotia Health Authority, Dalhousie University
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Responsible Party: Lisa Barrett, Principal Investigator, Nova Scotia Health Authority Identifier: NCT02460133    
Other Study ID Numbers: SAIL-001
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors