ISRCTN17508886已完成4 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
niversity of Sussex0 个研究点目标入组 19 人开始时间: 2020年4月23日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 16/06/2022:
- •1. HIV-1 positive
- •2. Age =18 years
- •3. Plasma HIV RNA <50 copies/ml at screening and on at least one other occasion over the last 12 months
- •4. Acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
- •5. On a stable antiretroviral regimen comprising of dolutegravir plus either one or two NRTIs once daily for >4 months
- •6. A total score of =8 on the Insomnia Severity Index
- •7. BMI =18
- •Previous participant inclusion criteria as of 03/03/2022:
- •1. HIV-1 positive
- •2. Age =18 years
- •3. Plasma HIV RNA <50 copies/ml at screening and on at least one other occasion over the last 12 months
- •4. Acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
- •5. On a stable antiretroviral regimen comprising of dolutegravir plus either one or two NRTIs once daily for >4 months
- •6. A total score of =8 on the Insomnia Severity Index
- •7. BMI of 18-32, inclusive
- •Previous participant inclusion criteria as of 17/06/2021:
- •1. HIV-1 positive
- •2. Age =18 years
- •3. Plasma HIV RNA <50 copies/ml at screening and on at least one other occasion over the last 12 months
- •4. Acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
- •5. On a stable antiretroviral regimen comprising of Triumeq™ once daily for >4 months
- •6. A total score of =8 on the Insomnia Severity Index
- •7. BMI of 18-32, inclusive
- •Previous participant inclusion criteria:
- •1. HIV-1 positive
- •2. Age > = 18 years
- •3. Plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months
- •4. Acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
- •5. On a stable antiretroviral regimen comprising of Triumeq™ once daily for > 4 months
- •6. A total score of 8 or greater in the Insomnia Severity Index
- •7. BMI 18 - 32, inclusive
排除标准
- •1. Significant neurological disease
- •2. Current history of major depression or psychosis
- •3. Diagnosed sleep disorder (sleep apnoea, narcolepsy)
- •4. Current medication which is likely to interfere with sleep
- •5. Recent head injury (past 30 days)
- •6. Current alcohol abuse or drug of abuse dependence
- •7. Active opportunistic infection or significant co-morbidities
- •8. Pregnancy
研究者
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