Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations

This study is ongoing, but not recruiting participants.
Sponsor:
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: July 8, 2014
Last verified: July 2014

January 20, 2012
July 8, 2014
January 2012
July 2014   (final data collection date for primary outcome measure)
Finish the standard treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Blood samples will be drawn while the subject is on treatment.
Same as current
Complete list of historical versions of study NCT01517529 on ClinicalTrials.gov Archive Site
Clearance of virus [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Blood samples will be drawn while the subject is on treatment.
Same as current
Not Provided
Not Provided
 
Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy

The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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.

Hepatitis C
Not Provided
20 Hepatitis C infected subjects
20 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2014
July 2014   (final data collection date for primary outcome measure)

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:

  1. Male or female
  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:

  1. Treatment naïve chronically HCV-infected patients.
  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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01517529
UC 11101915
No
Mohamed Tarek Shata, University of Cincinnati
University of Cincinnati
Merck Sharp & Dohme Corp.
Principal Investigator: Mohamed Tarek. M Shata, MD, PhD University of Cincinnati
University of Cincinnati
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP