Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
|ClinicalTrials.gov Identifier: NCT01517529|
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : September 30, 2015
Last Update Posted : November 20, 2015
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||December 2014|
10 Hepatitis C infected subjects
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.
- Number of Participants Who Completed Standard Treatment [ Time Frame: 9 months ]Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.
- Number of Participants Who Cleared the Virus [ Time Frame: 9 months ]Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517529
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Mohamed Tarek. M Shata, MD, PhD||University of Cincinnati|