EFFICACY AND SAFETY OF PROSAPTIDE FOR THE RELIEF OF NEUROPATHIC PAIN

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这将是一项随机、双盲、安慰剂对照的多中心研究设计，使用4个剂量水平(2、4、8和16毫克/天)来评估丙肽缓解与HIV-1相关的神经病理性疼痛的有效性和安全性。当200名受试者完成6周的治疗后，将进行中期分析。受试者将被淘汰辅助止痛药，包括抗惊厥药、抗抑郁药、局部止痛药和短效麻醉药。在每个研究地点，长效阿片类止痛药(在整个研究过程中保持每日恒定剂量)将被允许在多达20%的筛查对象中使用。服用长效麻醉药的受试者必须在就诊前至少90天内每天服用恒定剂量。所有受试者都将获得500毫克的对乙酰氨基酚片剂作为抢救药物。尽管接受了抢救药物，但仍有无法忍受的疼痛的受试者可以随时停止研究。双盲阶段将包括为期6周的积极治疗阶段，受试者接受4种剂量水平的丙氨酸肽或安慰剂。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This will be a randomized, double-blind, placebo-controlled multicenter study design using four dosing levels (2, 4, 8, and 16 mg/day) to evaluate the efficacy and safety of prosaptide for the relief of neuropathic pain associated with HIV-1. An interim analysis will be performed when 200 subjects complete 6 weeks of treatment. Subjects will be washed out of adjuvant pain medications including anticonvulsants, antidepressants, topical analgesics, and short acting-narcotics. Long acting opioid analgesics (maintained at a constant daily dose throughout the study) will be permitted in up to 20% of screened subjects at each study site. Subjects taking long-acting narcotics must have received a constant daily dose for at least 90 days prior to Visit 1. All subjects will receive a supply of acetaminophen 500 mg tablets as rescue medication. Subjects who have intolerable pain despite rescue medication are permitted to discontinue from the study at any time. The double-blind phase will include a 6 week active treatment phase with subjects receiving one of 4 dosing levels of prosaptide or placebo.