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

Hepatitis C Clinical Trial

Official title: Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis C

• NCT number: NCT01517529
• Study type: Observational
• Source: University of Cincinnati
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Completion date: December 2014