EFFICACY AND SAFETY OF PROSAPTIDE FOR THE RELIEF OF NEUROPATHIC PAIN

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这将是一项随机、双盲、安慰剂对照的多中心研究设计，采用四种剂量水平（2,4,8和16mg /天）来评估prosaptide缓解与HIV-1相关的神经性疼痛的有效性和安全性。当200名受试者完成6周的治疗时，将进行中期分析。受试者将不再使用辅助止痛药物，包括抗惊厥药、抗抑郁药、局部镇痛药和短效麻醉剂。长效阿片类镇痛药（在整个研究过程中保持每日恒定剂量）将被允许用于每个研究地点多达20%的筛选受试者。服用长效麻醉剂的受试者必须在第一次就诊前至少90天内每日服用固定剂量。所有受试者将获得500mg对乙酰氨基酚片作为抢救药物。尽管使用了救援药物，但仍有无法忍受的疼痛的受试者可随时退出研究。双盲期包括为期6周的积极治疗期，受试者接受4种剂量水平的prosaptide或安慰剂之一。

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.