Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy|
- Finish the standard treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]Blood samples will be drawn while the subject is on treatment.
- Clearance of virus [ Time Frame: 9 months ] [ Designated as safety issue: No ]Blood samples will be drawn while the subject is on treatment.
Biospecimen Retention: Samples With DNA
Blood lymphocytes from enrolled subjects will be retained until all investigations will be performed and publications are generated. After that remaining samples will be discarded properly according to the Biosafety instructions.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
20 Hepatitis C infected subjects
20 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517529
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Mohamed Tarek. M Shata, MD, PhD||University of Cincinnati|