NCT01517529

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2012-01-25
• Last updated: 2015-11-20
• Results posted: 2015-09-30

Locations

1 site across 1 country: United States