Curing HCV at Mount Sinai in Patients at High Risk for Disease Progression: HIV/HCV Co-infection and Type 2 Diabetes, New Solutions to the Challenge of Eliminating HCV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in the Number of Patients with sCD163 above the upper limit of normal
研究概览
简要总结
Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of treatment).once treatment candidates have been identified through this proactive approach, their providers will be directly notified. HCV champions and patient navigators will be used to further lower barriers to the delivery of HCV care. They will be co-located at non-hepatology care sites and will help deliver open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients and 200 patients with type 2 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection
- •18 years of age or older
- •HCV RNA positive
- •Any HCV genotype
- •Documented infection with HIV, with the following additional criteria: - Patients on HAART should be on a stable regimen for 4 weeks, with a CD4 count > 100, and an HIV viral load < 50 prior to initiation of HCV therapy Patients not on HAART should have a CD4 count > 350
- •Expected life expectancy sufficient to receive a benefit from HCV cure
- •No conditions that are contraindications for the use of HCV medications
- •Inclusion criteria for HCV treatment in patients with type 2 diabetes
- •18 years of age or older
- •HCV RNA positive
- •Any HCV genotype
- •Documented diagnosis of type 2 diabetes, confirmed by medical record review by the study endocrinologist, Dr. Sherley Abraham
- •Expected life expectancy sufficient to receive a benefit from HCV cure
排除标准
- •No conditions that are contraindications for the use of HCV medications
结局指标
主要结局
Change in the Number of Patients with sCD163 above the upper limit of normal
时间窗: baseline and 3 years
Change in the Number of Patients with sCD163 above the upper limit of normal at 3 years from baseline
Number of Type 2 Diabetes patients that initiate HCV treatment
时间窗: 3 years
The number of patients that initiate HCV treatment per month per patient navigator.
次要结局
- sCD163(3 years)
- Percentage of patients in need of repeated re-treatment(3 years)
- HOMA-IR(3 years)
- FIB-4 score(3 years)
- Number of resistance associated variant (RAV)(3 years)
- HCV cure rate(3 years)
研究者
Andrea Branch
Professor, Liver Diseases
Icahn School of Medicine at Mount Sinai