Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of participants with change in neurocognitive impairment defined by Global Deficit Score (GDS) > or equal to 0.5 related to HCV treatment
研究概览
简要总结
This study observes the effects of newly developed direct-acting antiviral (DAA) treatments on the central nervous system (CNS) of individuals with chronic Hepatitis C (HCV). The goals of this study are to determine the CNS impact of curing chronic HCV disease with newly established DAA therapies and how HIV alters this relationship.
详细描述
The specific aims of the study are as follows:
Aim 1. Impact of HCV Cure on CNS Outcomes. Determine how curing HCV without IFN alters CNS outcomes in substance users with chronic HCV disease.
Aim 2. Correlates of CNS Outcomes. Determine the viral and host correlates of Aim 1's neurocognitive outcomes.
Aim 3. Impact of HIV Co-infection. Explore how HIV alters the relationships observed in Aims 1 and 2. Hypothesis 3: Compared with HCV mono-infected adults, SVR will be less likely to result in improved CNS outcomes in HCV/HIV co-infected adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants with change in neurocognitive impairment defined by Global Deficit Score (GDS) > or equal to 0.5 related to HCV treatment
时间窗: 5 years
Neurocognitive impairment, defined as GDS \> or equal to 0.35, will be tested using a battery of tests covering 7 neurocognitive ability domains that include verbal fluency, information processing speed, learning, memory, executive functions, attention and working memory, fine motor skills.
次要结局
- Number of participants with abnormal laboratory values representing viral and host factors related to HCV treatment(5 years)
- Number of HIV-infected participants with abnormal laboratory values representing viral and host factors related to HCV treatment(5 years)
研究者
Ajay Bharti
Assistant Professor
University of California, San Diego