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

University of Cincinnati10 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis C

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Number of Participants Who Completed Standard Treatment

Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.

Time frame: 9 months

Secondary Outcomes

Number of Participants Who Cleared the Virus

Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses

Time frame: 9 months

Data from ClinicalTrials.gov

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