Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
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|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|
|Primary Completion Date :||July 2014|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|