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

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。设计：一项多中心、开放标签、为期24周的试验性研究，使用剂量递增的乙酰左旋肉碱（ALC）治疗hiv感染受试者中与二脱氧核苷相关的远端对称周围神经病变（DSPN）。每6周进行疼痛评分和安全性评估。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：hiv -1感染的双脱氧核苷相关DSPN受试者。神经性症状的出现或恶化必须与（在开始使用一种或多种二脱氧核苷类似物后12个月内发生）或与一种或多种二脱氧核苷类似物的剂量增加有关。在现场神经科医生看来，神经病变的出现或恶化必须归因于，至少部分，二脱氧核苷的使用。方案：受试者将开始使用ALC 500mg，每日两次，然后逐渐增加剂量至目标剂量1500mg，每日两次。在研究期间（24周，包括3周剂量递增阶段），受试者将继续使用1500毫克剂量或最大耐受剂量。

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).