A5157 "PILOT STUDY OF ACETYL-L-CARNITINE IN DSPN"

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。设计：一项多中心、开放标签、24周的先导性研究，采用剂量递增的乙酰化L肉碱治疗与双脱氧核苷相关的HIV感染者的远端对称性周围神经病。每6周将获得一次Gracely疼痛等级评估和安全信息。在基线和24周时进行表皮内神经纤维和皮下脂肪组织活检。持续时间：24周样本量：36名受试者人群：患有双脱氧核苷相关DSPN的HIV-1感染者。神经性症状的出现或恶化必须与一个或多个双脱氧核苷类似物的启动或一个或多个双脱氧核苷类似物的剂量递增有关(发生在12个月内)。根据现场神经科医生的观点，神经病的出现或恶化必须至少部分归因于双脱氧核苷的使用。方案：受试者将从每天两次服用ALC 500毫克开始，然后将剂量增加到每天两次的目标剂量1500毫克。受试者在研究期间(24周，包括3周的剂量递增阶段)将保持1500毫克的剂量或最大耐受量。

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. DESIGN: A multicenter, open-label, 24-week pilot study with dose escalation of acetyl-L-carnitine (ALC) for the treatment of distal symmetric peripheral neuropathy (DSPN) associated with dideoxynucleosides in HIV-infected subjects. Gracely pain scale assessments and safety information will be obtained every 6 weeks. An intraepidermal nerve-fiber and subcutaneous adipose tissue biopsy will be obtained at baseline and 24 weeks. DURATION: 24 weeks SAMPLE SIZE: 36 subjects POPULATION: HIV-1-infected subjects with dideoxynucleoside-associated DSPN. The appearance or worsening of the neuropathic symptoms must be associated with (have occurred within 12 months of) the initiation of one or more dideoxynucleoside analogues or with a dose-escalation of one or more of the dideoxynucleoside analogues. In the opinion of the site neurologist, the appearance or worsening of neuropathy must be attributable, at least in part, to dideoxynucleoside use. REGIMEN: Subjects will begin with ALC 500 mg twice daily and escalate dosage to a target dose of 1500 mg twice daily. Subjects will remain on the 1500-mg dose or a maximum tolerated dose for the duration of the study (24 weeks, which includes the 3-week dose-escalation phase).