AMITRIPTYLINE AND MEXILITINE FOR PAINFUL NEUROPATHY IN HIV INFECTION

阿米替林和美西汀治疗 HIV 感染引起的疼痛性神经病

• 批准号: 6445212
• 负责人: KARL D. KIEBURTZ
• 金额: $ 14.03万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-05-01 至 2002-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6445212
• 关键词: HIV infections; analgesics; antiarrhythmic agent; antidepressants; benztropine; clinical trials; dosage; drug screening /evaluation; human subject; human therapy evaluation; neurologic manifestations; pain

This Project will evaluate the effectiveness of amitriptyline and mexilitene in relieving pain symptoms in patients with HIV-related painful neuropathy. The study is a three arm parallel group, placebo controlled clinical trial, with subjects randomly assigned to receive on of three treatments: amitriptyline, mexilitene or placebo. The does will be titrated upward during the initial 4 weeks of the trial, then maintained for the second four weeks of study. Benztropine will be used as an "active placebo". Response parameters will include a standardized neurological exam, a global assessment of pain response, and the requirement for additional analgesic agents. Serum levels of study drugs will be determined. It is calculated that 80 patients per arm (240 subjects total) will be required.

该项目将评估阿米替林和阿米替林的疗效 美西律缓解HIV相关患者疼痛症状的临床研究 痛苦的神经病。这项研究是一组三臂平行的安慰剂 对照临床试验，受试者随机分配接受 三种疗法中的一种：阿米替林、美西律或安慰剂。无名氏的意志 在试验的最初4周内向上滴定，然后 在第二个四周的学习中保持。将使用苯妥拉平 作为一种“活性安慰剂”。响应参数将包括标准化的 神经学检查，疼痛反应的全球评估，以及 对额外止痛药的要求。研究药物的血清水平 将会被确定。据计算，每支手臂有80名患者(240人 科目总数)将是必需的。