2024-511951-16-00已完成4 期
Phase IV, Randomized, Multicenter, Double-Blind Clinical Trial Designed to Evaluate the Safety and Appropriateness of Switching from DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control, and Neuropsychiatric Vulnerabilities: MIND Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 13
- 主要终点
- Proportion of neuropsychiatric adverse effects grade 2-4 (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11)
研究概览
简要总结
The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult >18 years diagnosed with HIV by standard microbiological techniques
- •Active antiretroviral treatment with DTG/3TC
- •Last HIV viral load performed on the participant in the 6 months prior to the visit screening < 50 copies/mL. If the participant does not have an HIV viral load <50 cop/mL performed in the 14 days prior to the screening visit, it will be necessary to confirm at screening visit that the participant's HIV viral load is <50 cop/mL
- •Prior clinical diagnosis, carried out by a qualified specialist physician, of any of the following pathologies: Insomnia Anxiety disorders Depressive disorders
排除标准
- •Allergy or intolerance to any of the components of BIC/FTC/TAF
- •History of active CNS infections
- •Active psychosis or suicidal ideation
- •Pregnant or lactating women, as well as women of childbearing age who do not commit to use at least two contraceptive methods
- •Any clinical or laboratory condition that in the opinion of the investigator will prevent the participant to complete the study procedures
- •Participant included in the neuroimaging substudy: Claustrophobia or presence of magnetizable body devices
结局指标
主要结局
Proportion of neuropsychiatric adverse effects grade 2-4 (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11)
Proportion of neuropsychiatric adverse effects grade 2-4 (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11)
次要结局
- Proportion of grade 2-4 adverse effects (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11)
- Proportion of ART discontinuations due to neuropsychiatric adverse effects.
- Proportion of ART discontinuations for any reason.
研究者
Investigación clínica
Scientific
Fundacion Seimc Gesida
研究点 (13)
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