Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
NCT ID: NCT01517529
Last Updated: 2015-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
10 participants
OBSERVATIONAL
2012-01-31
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Age 18 to 65
3. Chronic HCV infection evidenced by liver biopsy or persistent HCV viremia for \>6 months
4. Treatment experienced and classified as non-responder or relapser to prior interferon-based therapy.
Exclusion Criteria
2. Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.
3. Pregnancy
4. HIV
18 Years
65 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University of Cincinnati
OTHER
Responsible Party
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Mohamed Tarek Shata
Principal investigator
Principal Investigators
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Mohamed Tarek. M Shata, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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References
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Abdel-Hameed EA, Rouster SD, Ji H, Ulm A, Hetta HF, Anwar N, Sherman KE, Shata MT. Evaluating the Role of Cellular Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy. Viral Immunol. 2016 May;29(4):252-8. doi: 10.1089/vim.2015.0093. Epub 2016 Feb 17.
Other Identifiers
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UC 11101915
Identifier Type: -
Identifier Source: org_study_id