Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
研究概览
简要总结
The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
详细描述
A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling.
In addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing.
They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine.
Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated.
The proportion of patients reaching SVR will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Subjects must meet all of the following inclusion criteria to participate in this study.
- •Have voluntarily signed the consent form.
- •18 years of age or older.
- •HCV antibody positive.
- •HIV antibody positive.
排除标准
- •Subjects who meet any of the exclusion criteria are not to be enrolled in this study.
- •Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the subject treatment, assessment or compliance with the protocol.
- •Creatinine clearance (CLcr) < 30mL/min at screening.
- •Pregnant or nursing female.
- •Use of prohibited concomitant medications.
- •Inability or unwillingness to provide informed consent or abide by the study requirements.
结局指标
主要结局
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
时间窗: 12 weeks post completion of commenced treatment
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
次要结局
未报告次要终点