Status:
COMPLETED
Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Brief Summary
The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during 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 c...
Eligibility Criteria
Inclusion
- 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:
- Male or female
- Age 18 to 65
- Chronic HCV infection evidenced by liver biopsy or persistent HCV viremia for \>6 months
- Treatment experienced and classified as non-responder or relapser to prior interferon-based therapy.
- Exclusion criteria:
- Treatment naïve chronically HCV-infected patients.
- Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.
- Pregnancy
- HIV
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01517529
Start Date
January 1 2012
End Date
December 1 2014
Last Update
November 20 2015
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267