Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants Who Completed Standard Treatment
研究概览
简要总结
The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Completed Standard Treatment
时间窗: 9 months
Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.
次要结局
- Number of Participants Who Cleared the Virus(9 months)
研究者
Mohamed Tarek Shata
Principal investigator
University of Cincinnati