A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
研究概览
简要总结
A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be related to taking DTG/3TC/ABC, if they improve after switching antiretroviral therapy to the combination of ELV/COBI/FTC/TAF.
详细描述
we estimate that 64 participants will need to be enrolled in the study to demonstrate symptomatic improvement after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 18 years of age diagnosed with HIV using normal serology techniques.
- •Current antiretroviral therapy with DTG/3TC/ABC.
- •HIV viral load < 50 copies/mL for at least 12 weeks prior to signing the consent form [(]confirmed by two assays at least 12 weeks apart with viremia < 50 copies/mL between both). If the patient has a recent routine blood test available (≤ 4 weeks) that includes determining HIV viral load, these results may be used for the screening visit. If this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion.
- •Appearance or worsening of the following symptoms compared to when DTG/3TC/ABC was started:
- •Symptoms of anxiety or depression
- •Insomnia or other sleep disturbances
- •Cognitive complaints (attention, concentration or memory)
- •Alterations in behaviour (irritability, aggressiveness or agitation)
- •Dizziness of neurological or neurologically-mediated origin
排除标准
- •Determination of at least one HIV viral load ≥ 50 copies/mL in the last 12 weeks.
- •Allergy, intolerance or existence of resistance mutations to any of the components of ELV/COBI/FTC/TAF
- •History of active CNS infections
- •Active psychosis, major depression with psychotic symptoms or autolytic ideation
- •Dementia or mental retardation
- •Drug use with a diagnosis of abuse or dependence according to DSM-5 criteria
- •Illnesses that may interfere with the study procedures
- •Claustrophobia
- •Presence of magnetisable devices in the body
- •Inability to complete any of the study procedures
- •Pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.
研究组 & 干预措施
Arm 1
Patients who postpone switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF four weeks:
干预措施: DTG/3TC/ABC + ELV/COBI/FTC/TAF (Drug)
Arm 2
Patients who switch from DTG/3TC/ABC to ELV/COBI/FTC/TAF during the baseline visit
干预措施: ELV/COBI/FTC/TAF (Drug)
结局指标
主要结局
To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
时间窗: Week 4
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the depression scale.
次要结局
- Percentages of virologic failure(Week 24 after the switching)
- To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF(Week 4)
- To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF(Week 24 after the switching)