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。 阿米替林、美西律和安慰剂对 HIV相关的周围神经病变虽然阿米替林和美西律 在临床实践中常用，没有已发表的报告 这些药物在HIV相关外周血中的安全性或有效性 神经病变 参与者被随机分配接受其中一种 以下方案：阿米替林，从每晚25 mg开始，然后滴定 在长达四周的时间内，每晚最多可达100 mg。 患者将继续服用最后一剂药物至少4天。 周 美西来汀，开始在150毫克，在夜间和滴定向上， 最多300 mg bid，持续4周。 患者 保持该剂量的药物至少四周，或安慰剂， 苯扎托品用作活性安慰剂以匹配阿米替林。