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

Completed

• Conditions: Hepatitis C

• Registration Number: NCT01517529
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Results First Submitted: 2015-08-25
• Results First Submitted QC: 2015-08-27
• Results First Posted: 2015-09-30
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Completed Standard Treatment	9 months	Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Cleared the Virus	9 months	Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States