Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- University of Cincinnati
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Completed Standard Treatment
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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 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.
Investigators
Mohamed Tarek Shata
Principal investigator
University of Cincinnati
Eligibility 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:
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants Who Completed Standard Treatment
Time Frame: 9 months
Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.
Secondary Outcomes
- Number of Participants Who Cleared the Virus(9 months)