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
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Condition or disease |
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Hepatitis C |
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 |
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 |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | December 2014 |

Group/Cohort |
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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.
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- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria: All chronically HCV-infected patients who fail peg-IFN and RBV therapy and are eligible for combined treatment with PI therapy will be enrolled. Briefly, this includes:
- Male or female
- Age 18 to 65
- Chronic HCV infection evidenced by liver biopsy or persistent HCV viremia for >6 months
- Treatment experienced and classified as non-responder or relapser to prior interferon-based therapy.
Exclusion criteria:
- Treatment naïve chronically HCV-infected patients.
- Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.
- Pregnancy
- HIV

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mohamed Tarek Shata, Principal investigator, University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT01517529 History of Changes |
Other Study ID Numbers: |
UC 11101915 |
First Posted: | January 25, 2012 Key Record Dates |
Results First Posted: | September 30, 2015 |
Last Update Posted: | November 20, 2015 |
Last Verified: | October 2015 |
Keywords provided by Mohamed Tarek Shata, University of Cincinnati:
Hepatitis C HCV |
Additional relevant MeSH terms:
Hepatitis Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections |
Protease Inhibitors HIV Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |