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

A5157“DSPN 中乙酰左旋肉碱的试点研究”

• 批准号: 7381026
• 负责人: Jorge Santana
• 金额: $ 2.02万
• 依托单位: UNIVERSITY OF PUERTO RICO MED SCIENCES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7381026
• 关键词: A5157; PILOT; STUDY; ACETYL; CARNITINE

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).

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。产品设计：一项多中心、开放标签、24周的先导性研究，乙酰-L-肉碱（ALC）剂量递增治疗HIV感染受试者中与双脱氧核苷相关的远端对称性周围神经病变（DSPN）。Gracely疼痛量表评估和安全性信息将每6周获得一次。将在基线和24周时获得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例受试者 人群：患有双脱氧核苷相关DSPN的HIV-1感染受试者。 神经病性症状的出现或恶化必须与开始使用一种或多种双脱氧核苷类似物或一种或多种双脱氧核苷类似物的剂量递增相关（在12个月内发生）。研究中心神经科医生认为，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：受试者将开始接受ALC 500 mg每日两次，然后将剂量递增至目标剂量1500 mg每日两次。受试者将在研究期间（24周，包括3周剂量递增期）保持1500 mg剂量或最大耐受剂量。