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Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations

This study is currently recruiting participants.
Verified May 2013 by University of Cincinnati
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Mohamed Tarek Shata, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01517529
First received: January 20, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.


Condition
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Finish the standard treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Blood samples will be drawn while the subject is on treatment.


Secondary Outcome Measures:
  • Clearance of virus [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Blood samples will be drawn while the subject is on treatment.


Biospecimen Retention:   Samples With DNA

Blood lymphocytes from enrolled subjects will be retained until all investigations will be performed and publications are generated. After that remaining samples will be discarded properly according to the Biosafety instructions.


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
20 Hepatitis C infected subjects
20 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.

Detailed Description:

Objective 1: Evaluate the role of the immune responses in determining the emergence of HCV NS3 resistance mutation during protease inhibitor therapy

Hypothesis 1 (HT 1): Low HLA binding to peptides containing protease inhibitor resistance mutations is associated with the emergence of protease inhibitor mutants during therapy and failure of the treatment.

Hypothesis 2 (HT 2): A hole in T cell repertoire may allow emergence of protease inhibitor mutants during protease inhibitor therapy which leads to loss of the immune responses to these mutants and failure of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Investigators plan to enroll 20 human subjects with chronic hepatitis C virus infection from the outpatient clinic at the University of Cincinnati College of Medicine.

Criteria

Inclusion Criteria: All chronically HCV-infected patients who fail peg-IFN and RBV therapy and are eligible for combined treatment with PI therapy will be enrolled. Briefly, this includes:

  1. Male or female
  2. Age 18 to 65
  3. Chronic HCV infection evidenced by liver biopsy or persistent HCV viremia for >6 months
  4. Treatment experienced and classified as non-responder or relapser to prior interferon-based therapy.

Exclusion criteria:

  1. Treatment naïve chronically HCV-infected patients.
  2. Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.
  3. Pregnancy
  4. HIV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517529

Contacts
Contact: Diane Daria, RN 513-584-5245 diane.daria@uc.edu
Contact: Mohamed Tarek M Shata, MD, PhD 513-558-6110 mohamed.shata@uc.edu

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Diane Daria, RN     513-584-5245     diane.daria@uc.edu    
Contact: Mohamed Tarek M Shata, MD, PhD     513-558-6110     mohamed.shata@uc.edu    
Principal Investigator: Mohamed Tarek M Shata, MD, PhD            
Sub-Investigator: Kenneth E. Sherman, MD, PhD            
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Mohamed Tarek M Shata, MD. PhD     513-558-6110     mohamed.shata@uc.edu    
Principal Investigator: Mohamed Tarek M Shata, MD, PhD            
Sponsors and Collaborators
University of Cincinnati
Merck
Investigators
Principal Investigator: Mohamed Tarek. M Shata, MD, PhD University of Cincinnati
  More Information

No publications provided

Responsible Party: Mohamed Tarek Shata, Principal investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01517529     History of Changes
Other Study ID Numbers: UC 11101915
Study First Received: January 20, 2012
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Hepatitis C
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013