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: 6302835
• 负责人: KARL D. KIEBURTZ
• 金额: $ 27.36万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-05-01 至 2001-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6302835
• 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.

本项目将评估阿米替林的有效性， 美西力汀缓解HIV相关患者疼痛症状 疼痛性神经病 本研究为三臂平行组，安慰剂 对照临床试验，受试者随机分配接受 阿米替林、美西力汀或安慰剂。 母熊会 在试验的前4周内向上滴定，然后 在研究的第二个四周保持。 将使用苯扎托品 作为“活性安慰剂”。 响应参数将包括标准化的 神经系统检查，疼痛反应的整体评估，以及 需要额外的镇痛剂。 研究药物的血清水平 将被确定。 据计算，每组80例患者（240 受试者总数）。