MARCH Central Nervous System Substudy
Maraviroc Switch Central Nervous System (CNS) Substudy: a Substudy of MARCH, a Randomised, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc (MVC) as a Switch for Either Nucleoside or Nucleotide Analogue Reverse Transcriptase Inhibitors (N(t)RTI) or Boosted Protease Inhibitors (PI/r) in HIV-1 Infected Individuals With Stable, Well-controlled Plasma HIV-RNA While Taking Their First N(t)RTI + PI/r Regimen of Combination Antiretroviral Therapy (cART).
This substudy is a prospective, observational, open-label, randomised study within the MARCH study. The purpose of this substudy is to investigate the changes in cerebral function parameters at 5 timepoints over 96 weeks of the three different treatment arms within the MARCH study. The investigators hypothesise that there will be improvements in cerebral function in those patients randomised, as part of the parent study, into the maraviroc arms.
the assessments in this CNS substudy will include:
- Neurocognitive function as assessed by a computerised testing battery called CogState;
- changes in cerebral metabolites as measured via 1H Magnetic Resonance Spectroscopy (1H-MRS)
In those randomised to the maraviroc arms (arms 2 and 3) there is an optional Lumbar puncture at week 48. The cerebrospinal fluid will be used to measure maraviroc levels and an ultrasensitive CSF HIV-1 viral load. These results will be matched with levels in the plasma.
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Provision of written, informed consent for participation in the substudy
- Enrolled into the substudy either at or before the week 0 visit of the main study
Exclusion Criteria:
- Pre-existing CNS diseases
- Recent head injury (past three months)
- Current history of major depression or psychosis
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
NRTI + PI
This is the randomisation of the main study, Arm 1
|
NRTI+PI
其他名称：
|
|
maraviroc + PI
this is the randomisation of the main study, Arm 2
|
maraviroc + PI
其他名称：
|
|
maraviroc + NRTI
this is the randomisation of the main study, Arm 3
|
maraviroc + NRTI
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To assess changes in NC function over 96 weeks, measured via a computerised testing battery in HIV-infected subjects stable on antiretroviral therapy randomised to three different treatment approaches
大体时间：96 weeks
|
using CogState testing at 5 timepoints, weeks 0, 12, 24, 48, 96
|
96 weeks
|
|
To assess changes in cerebral metabolites over 96 weeks, measured via 1H Magnetic Resonance Spectroscopy (1H-MRS), in HIV-infected subjects stable on antiretroviral therapy randomised to three different treatment approaches
大体时间：96 weeks
|
Assessment of CNS metabolites via 1H-MRS at week 0, 48, 96
|
96 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
to assess CSF HIV-1 RNA and CSF maraviroc concentration (in the MVC treatment arms) versus plasma HIV -1 RNA and MVC concentration after 48 weeks of therapy
大体时间：48 weeks
|
A LP examination at week 48 (optional and only in the MVC treatment arms, and only if there is no contraindication to LP) to assess, with matched plasma samples:
|
48 weeks
|
合作者和调查者
调查人员
- 首席研究员：Alan Winston, MD、Imperial Healthcare, London, UK
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MARCH-Kirby CNS
- 2011-002107-15 (EudraCT编号)
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