PHASE II/III DOUBLE-BLIND STUDY OF AMYTRYPTILENE/MEXILETINE FOR HIV NEUROPATHY

阿米替林/美西律治疗 HIV 神经病的 II/III 期双盲研究

• 批准号: 6275358
• 负责人: Robert Turner Schooley
• 金额: $ 3.14万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6275358
• 关键词: AIDS /HIV neuropathy; AIDS therapy; HIV infections; amitriptyline; analgesics; clinical research; human subject; human therapy evaluation; mexiletine; nervous system disorder chemotherapy; pain

This study was a three- arm, parallel-group, placebo-controlled clinical trial to compare the effects of amitriptyline, mexiletine and placebo on HIV-related peripheral neuropathy. Although amitriptyline and mexiletine are commonly used in clinical practice, there are no published reports of the safety or efficacy of these agents in HIV-related peripheral neuropathy. Participants were randomly assigned to receive one of the following regimes: amitriptyline, started at 25 mg nightly, then titrated upward to a maximum of 100 mg nightly, over a period of up to four weeks. Patients were to remain on the final dose of medication for at least four weeks. Mexilletine, started at 150 mg at night and titrated upward to a maximum of 300 mg bid, over a period of up to four weeks. Patients were to remain on that dose of medication for at least four weeks, or placebo, benztropine was used as an active placebo to match amitriptyline.

本研究是一项三组、平行组、安慰剂对照的临床研究 比较阿米替林、美西律和安慰剂的效果的试验 HIV相关的周围神经病变。虽然阿米替林和美西律 临床上常用，目前尚未见报道 这些药物在 HIV 相关外周疾病中的安全性或有效性 神经病。 参与者被随机分配接受其中一项 以下方案：阿米替林，每晚 25 毫克开始，然后滴定 每晚最多服用 100 毫克，持续时间长达 4 周。 患者应继续服用最后一剂药物至少四年 几周。 美西律，每晚起始剂量为 150 mg，逐步滴定至 最多 300 mg bid，持续长达 4 周。 患者是 继续服用该剂量的药物至少四个星期，或服用安慰剂， 苯托品被用作活性安慰剂来匹配阿米替林。