NCT03732625Unknown4 期
Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Evaluate improvement in neuropsychiatric symptoms at 12 weeks (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events)
研究概览
简要总结
Open, multicenter, non randomized, single arm, pilot trial.
详细描述
Open, multicenter, non randomized, single arm, pilot trial. The study is aimed at patients infected with HIV in triple antiretroviral therapy based on Dolutegravir (DTG) who experience neuropsychological adverse effects related to the treatment. After signing the informed consent, DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age ≥ 18 years.
- •Infection with chronic HIV-
- •On triple therapy antiretroviral therapy based on abacavir/lamivudine (ABC/3TC) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC), whose third component is DTG in a dose of 50 mg / day.
- •Presence of neuropsychiatric symptoms (insomnia, sleep disturbances, reduced concentration, dizziness, headaches, depression, restlessness or nervousness) with an intensity ≥ 2 on the DAIDS scale.
- •Written informed consent to participate in the study.
- •Exclusion criteria:
- •Pregnant women, nursing or of childbearing age who want to get pregnant.
- •Concomitant use of any medication with potential risk of interaction with the therapy under study.
- •Intolerance, hypersensitivity or previous resistance to the therapy under study or presence of any contraindication of it.
- •Subjects in therapy with immunosuppressants or chemotherapy with cytotoxics, including interferon and interleukin-2 at the time of their inclusion in the study.
- •Abuse of alcohol or any other substance that may interfere with adherence to treatment.
- •Subjects who are participating in any other clinical study with the exception of those in which the treatment under study has been suspended for more than 12 weeks.
- •AIDS event at the time of diagnosis of HIV infection or in the 3 months prior to its inclusion
- •Any other clinical condition or previous treatment that makes the subject unsuitable for the study or that compromises their ability to comply with the treatment dosing requirements.
- •History of mental illness or diagnosis of neuropsychological symptoms prior to the use of DTG.
- •Presence of genotypic mutations that confer resistance to ABC, TDF / TAF, 3TC or FTC.
- •Chronic liver disease in the cirrhosis phase (either by ultrasound criteria or fibroscan ≥ 14.5 KPa)
- •Consumption of tobacco ≥ 20 cigarettes / day.
- •Additional Exclusion Criteria (for patients recruited at the Costa del Sol Hospital in Marbella only):
- •History or diagnosis of claustrophobia, or inability to lie flat on the back inside the positron emission tomograph or MRI chamber for a period of 20 minutes.
- •Contraindication to perform an MRI, including the presence of a cardiac pacemaker or other electronic device or ferromagnetic metallic foreign bodies in vulnerable positions evaluated by a standard questionnaire prior to MRI.
排除标准
- 未提供
研究组 & 干预措施
Raltegravir
Experimental
Raltegravir (RAL) x 2 600mg QD (Total 1200mg QD)
干预措施: Raltegravir (Drug)
结局指标
主要结局
Evaluate improvement in neuropsychiatric symptoms at 12 weeks (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events)
时间窗: 12 weeks
Evaluate improvement in neuropsychiatric symptoms: grade 1 to 4 of DAIDS scale. higher values represent a worse outcome
次要结局
- Change in quality of life (WHOQoL-bref questionnaire)(24 weeks)
- Variation of the result in the Hospital, Anxiety and Depression (HAD) scale(24 weeks)
- Variation of the result on the Pittsburgh Sleep Quality Index (PSQI) scale(24 weeks)
- Variation of the result in the Epworth scale(24 weeks)
- Variation of the result in the COLUMBIA-SUICIDE SEVERITY RATING (CSSR) scale(24 weeks)
- Magnetic Resonance Imagigng (MRI) analysis for 10 of the patients recruited at the Costa del Sol Hospital (pilot subestudy)(24 weeks)
- Neuropsychiatric symptoms(24 weeks)
- Interruptions of the medication for any reason(24 weeks)
研究者
研究点 (3)
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