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

University of Cincinnati

Status: Completed

Conditions: Hepatitis C

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01517529

UC 11101915

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

10 participants in 1 patient group

10 Hepatitis C infected subjects

Description:

10 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.