EUCTR2019-004007-12-GB进行中（未招募）1 期
Brain connectivity and patient reported outcomes in people with HIV (PWH) with symptoms of insomnia switching integrase inhibitor-based ART; a randomised controlled study - BIC CNS Study
niversity of Sussex0 个研究点目标入组 46 人开始时间: 2020年3月2日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- HIV-1 positive
- •- age = 18 years
- •- plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months
- •- acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
- •- On a stable antiretroviral regimen comprising of Triumeq™ once daily for >4 months
- •- A total score of 8 or greater in the Insomnia Severity Index
- •- BMI 18 - 32, inclusive
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •- Significant neurological disease
- •- Current history of major depression or psychosis
- •- Diagnosed sleep disorder (sleep apnoea, narcolepsy)
- •- Current medication which is likely to interfere with sleep
- •- Recent head injury (past 30 days)
- •- Current alcohol abuse or drug of abuse dependence
- •- Active opportunistic infection or significant co-morbidities
- •- Pregnancy
研究者
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