CTNPT 015 - Pilot Project to Implement a Step-wise Investigation That Includes Cerebrospinal (CSF) Analysis as a Standard of Care for HIV+ Individuals With Cognitive Symptoms
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Changes in neurocognitive functioning over 6 months
研究概览
简要总结
The purpose of this study is to contribute evidence towards the potential to improve cognition in HIV+ individuals experiencing cognitive decline through personalized change in antiretroviral (ARV) medication. To that end, following a comprehensive evaluation to identify confounding clinical conditions, study participants will undergo a lumbar puncture to: (i) measure viral load (at 2 copies/ml); (ii) identify Cerebrospinal Fluid (CSF) genotype and tropism; and (iii) measure concentration of antiretroviral agents. When indicated from the CSF analysis, a personalized change in ARV will be implemented. Cognition will be measured in all at study entry and 6 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •are 18 years and older
- •have the capacity to give informed consent as determined by the research nurse
- •have unexplained cognitive decline (reported either by the patient or an outside informant)
- •have been on a stable ART regimen for > 6 months
- •have an undetectable viral load in plasma for at least 6 months (a single blip of ≤ 150 copies/mL will be accepted)
- •have not had a change in medications that could potentially interfere with cognition in the past 4 months
排除标准
- •detectable VL in the plasma
- •past history of dementia
- •past history of Central Nervous System opportunistic infection or stroke
- •current substance abuse ( as per DSM-IV criteria) other than cigarettes
- •coagulopathy
- •thrombocytopenia
- •use of Coumadin
- •intra-cranial hypertension
研究组 & 干预措施
Change in ARVs to improve cognition
Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis
干预措施: Change in antiretrovirals (Drug)
结局指标
主要结局
Changes in neurocognitive functioning over 6 months
时间窗: 6 months
Cognition will be assessed at study entry and 6 months with the following tests: Letter Fluency, Category Fluency, Letter-Number Sequencing, Digit-Symbol, Symbol Search, Grooved Pegboard, Hopkins Verbal Learning Test-Revised, Stroop, Brief Visuospatial Memory Test-Revised, Tower of London, Trail Making Test A and B, Spatial Span, Montreal Cognitive Assessment (MoCA), and a brief computerized battery of tests (B-CAM).
次要结局
未报告次要终点
研究者
Marie-Josée Brouillette
Associate Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre