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Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
This study has been completed.
Sponsor:
University of Cincinnati
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mohamed Tarek Shata, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01517529
First received: January 20, 2012
Last updated: October 20, 2015
Last verified: October 2015
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Purpose
The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.
| Condition |
|---|
| Hepatitis C |
| Study Type: | Observational |
| 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 |
Resource links provided by NLM:
Further study details as provided by Mohamed Tarek Shata, University of Cincinnati:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
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.
| Enrollment: | 10 |
| Study Start Date: | January 2012 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Investigators plan to enroll 20 human subjects with chronic hepatitis C virus infection from the outpatient clinic at the University of Cincinnati College of Medicine.
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517529
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517529
Locations
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
Sponsors and Collaborators
University of Cincinnati
Merck Sharp & Dohme Corp.
Investigators
| Principal Investigator: | Mohamed Tarek. M Shata, MD, PhD | University of Cincinnati |
More Information
| Responsible Party: | Mohamed Tarek Shata, Principal investigator, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01517529 History of Changes |
| Other Study ID Numbers: |
UC 11101915 |
| Study First Received: | January 20, 2012 |
| Results First Received: | August 25, 2015 |
| Last Updated: | October 20, 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 |
ClinicalTrials.gov processed this record on September 21, 2017