Observational Prospective Trial to Investigate the Impact of Antiretroviral Therapy Initiation With Integrase Strand Transfer Inhibitors on Brain Outcomes:The ARBRE Study:Impact of AntiRetroviral Therapy With INSTI on BRain outcomEs (ARBRE) According to the Time of Therapy Initation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Change in Global Cognitive Functioning
研究概览
简要总结
The ARBRE Study is an observational prospective trial aimed at investigating the impact of the therapy initiation with INTIs on brain outcomes according to the time of therapy initiation. Three study arms are considered: 1) Early treated HIV-1 infected patients (<3 months since estimated date of infection), 2) Regularly treated HIV-1 infected patients (>6 months since estimated date of infection), 3) Matched seronegative control group. Study assessments will be performed at baseline, 1 month and 12 months. Study assessments will comprise comprehensive evaluation of brain outcomes. They will include cognitive functioning, neuroimaging parameters, and functional outcomes.
详细描述
Randomized patients will receive LA CAB+RPV administration in the hospital (standard of care) or out-of- hospital administration every 2 months (M2, M4, M6, M8,M10, M12). Medical visits, rutinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline, M1 (if patient has not previously receiving LA CAB+RPV), M6 and M12.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old
- •Voluntary participation.
- •Signed written consent.
- •Confirmed HIV-1 infection (for arms A and B).
- •Intention to initiate therapy with cART containing an INSTI. Specifically, the regimen included raltegravir, elvitegravir or dolutegravir.
排除标准
- •Prior diagnosis of opportunistic infection involving CNS.
- •Current diagnosis of psychiatric disorder.
- •Current or past diagnosis of neurologic disease.
- •Inability to develop any of the tasks required for the study.
- •Pregnancy.
- •History of suboptimal adherence (for arms A and B).
结局指标
主要结局
Change in Global Cognitive Functioning
时间窗: From Baseline to Week 48
The measure used will be NPZ-12 (NeuroPsychological Z-12). Minimum value: -5 Maximum value: +5. Mean: 0. Lower score will represent worse global cognitive functioning; higher score will represent better global cognitive functioning.
次要结局
- Change in Neuroimaging Markers(From Baseline to Week 48)
- Change in Depressive Symptoms(From baseline to week 48)
- Change in Anxiety Symptoms(From Baseline to Week 48)
- Change in Neuropsychiatric Symptoms(From Baseline to Week 48)
- Change in Daily Living Functioning(From Baseline to Week 48)
- Change in Daily Perceived Stress(From baseline to week 48)
- Change in Quality of Life(From Baseline to Week 48)