EUCTR2018-004885-32-IT进行中（未招募）1 期
THE EFFECTS OF SWITCHING FROM DOLUTEGRAVIR/LAMIVUDINE/ABACAVIR (D/L/A) TO BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE (B/F/TAF) IN PATIENTS WITH SUPPRESSED VIRAL LOAD ON NEUROPSYCHIATRIC SIDE EFFECTS AND NEUROCOGNITIVE FUNCTION - DOBINeuro
AZIENDA OSPEDALIERA UNIVERSITARIA SENESE0 个研究点目标入组 100 人开始时间: 2021年5月20日最近更新:
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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
- 100
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
- •-Age >18 years
- •-HIV-1 infection
- •-HIV RNA <50 copies/mL >12 months (including patients with 1 blip 50-200 cp/ml before screening not confirmed)
- •-On treatment with dolutegravir/abacavir/lamivudine >6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Previous AIDS events
- •-Pregnancy or pregnancy plan
- •-Decompensated cirrhosis (Child B or C)
- •-Intake of alcohol, substances, other drugs that may affect neurocognitive performance
- •-Necessity to receive drugs that may require dosing adjustment of dolutegravir or bictegravir
- •-Certified diagnosis of major depression, psychosis, history of suicidal attempts
- •-Treatment with antidepressants or antipsychotic drugs
- •-History of virological failure with integrase inhibitors
- •-Lack of knowledge of italian language
- •-Impossibility to obtain informed written consent
- •-HBsAg positivity
- •-Estimated glomerular filtration rate by CK-EPI <50 ml/min per 1.73m2
研究者
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