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).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
this is detailed above, this is a substudy of MARCH
研究设计
- 研究类型
- Observational
- 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
- •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
排除标准
- •Pre-existing CNS diseases
- •Recent head injury (past three months)
- •Current history of major depression or psychosis
研究组 & 干预措施
NRTI + PI
This is the randomisation of the main study, Arm 1
干预措施: Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors (Drug)
maraviroc + PI
this is the randomisation of the main study, Arm 2
干预措施: Arm 2 Maraviroc and Protease Inhibitors (Drug)
maraviroc + NRTI
this is the randomisation of the main study, Arm 3
干预措施: Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors (Drug)
结局指标
主要结局
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
时间窗: 96 weeks
using CogState testing at 5 timepoints, weeks 0, 12, 24, 48, 96
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
时间窗: 96 weeks
Assessment of CNS metabolites via 1H-MRS at week 0, 48, 96 * Cerebral metabolites in frontal white and grey voxels, and basal ganglia will be measured * Measurable metabolites will include assessment of neuronal markers, N-acetyl-aspartate, and inflammatory markers, myo-Inositols and Choline
次要结局
- 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(48 weeks)