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AMITRIPTYLINE AND MEXILITINE FOR PAINFUL NEUROPATHY IN HIV INFECTION

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
项目类别：
财政年份：
2000
资助国家：
美国
项目状态：
已结题
起止时间：
2000-05-01 至 2001-04-30
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

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英文摘要
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.
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