Phase II Developmental Study on Fatigue in AIDS Patients

艾滋病患者疲劳的二期发展研究

• 批准号: 6659029
• 负责人: Ricardo Alberto Cruciani
• 金额: $ 21.29万
• 依托单位: BETH ISRAEL MEDICAL CTR (NEW YORK)
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-15 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6659029
• 关键词: AIDS; AIDS dementia complex; AIDS therapy; blood chemistry; carnitine; clinical research; clinical trial phase II; dietary supplements; emotions; fatigue; human subject; human therapy evaluation; medical complication; nutrition related tag; outcomes research; patient oriented research; performance; psychomotor function; quality of life

DESCRIPTION (provided by applicant): Fatigue is a commonly reported symptom in patients with AIDS. The causes of fatigue are multifactorial and include the disease itself, antiviral therapies, anemia, depression and malnutrition. Our preliminary data suggest that micronutrient deficiencies, specifically carnitine deficiency, may be an important factor in fatigue. Carnitine plays a major role in energy metabolism. Systemic depletion is characterized by weight loss, fatigue, muscle weakness, decreased tolerance to metabolic stress and cardiomyopathy. WE found deficiency of the micronutrient carnitine in 6/10 patients with end stage AIDS presenting with canitine deficiency. Symptoms of fatigue and functional status improved significantly in those patients who received oral L-carnitine supplementation. Objectives: a) to determine the effect of L-carnitine therapy on symptoms of fatigue in patients with terminal AIDS and serum carnitine deficiency; and b) to determine the effect of L-carnitine therapy on performance status, cognitive function, mood, quality of life, and motor activity in these patients. Study Design: We propose to conduct a Phase II developmental randomized double-blind placebo-controlled study to determine the effect of the micronutrient L-carnitine on fatigue and other outcomes in patients with terminal AIDS. A sample of 44 patients with terminal AIDS, fatigue and serum carnitine deficiency will be recruited into the intervention study. At the first visit, the patients will receive a baseline assessment of fatigue, performance status, cognitive function, mood, quality of life, and motor activity. a) During weeks 1-4, patients will be randomized to receive L-carnitine, 3g/day, or placebo. b) During weeks 5-8, all patients will receive L-carnitine dose at 3 g/day for a period of 4 weeks. The primary endpoint will be change in fatigue at 4 weeks. Analysis will evaluate group differences in the primary endpoint and outcomes. An interim analysis will be done once 15 patients have been observed in each group at 4 weeks. Paired and unpaired data analyses between groups will be conducted with the assistance of the statistician.

描述（由申请人提供）：疲劳是一种常见的症状， 艾滋病患者。疲劳的原因是多方面的，包括 疾病本身、抗病毒治疗、贫血、抑郁和营养不良。我们 初步数据表明，微量营养素缺乏，特别是 肉毒碱缺乏，可能是疲劳的一个重要因素。肉毒碱起着 在能量代谢中的重要作用。全身性消耗的特征是体重 损失，疲劳，肌肉无力，对代谢应激的耐受性降低， 心肌病我们发现6/10的人缺乏微量营养素肉毒碱 表现为犬瘟热缺乏的终末期艾滋病患者。症状 疲劳和功能状态在那些 口服左旋肉碱补充剂。 目的：a）确定L-肉碱治疗对症状的影响， 患有晚期AIDS和血清肉毒碱缺乏的患者的疲劳;和B） 以确定L-肉碱治疗对性能状态，认知功能， 功能、情绪、生活质量和运动活动。 研究设计：我们建议进行一项II期发育随机双盲研究， 安慰剂对照研究，以确定微量营养素的作用 左旋卡尼汀对艾滋病晚期患者疲劳和其他结局的影响一 44例艾滋病晚期患者疲劳与血清肉毒碱 将被招募到干预研究中。在第一次访问时， 患者将接受疲劳，行为状态， 认知功能、情绪、生活质量和运动活动。（a）周内 1 - 4，患者将随机接受左旋肉碱，3g/天，或安慰剂。B） 在第5 - 8周期间，所有患者将接受3g/天的L-肉碱剂量， 为期4周。主要终点将是第4周时疲劳的变化。 分析将评价主要终点和结局的组间差异。 一旦每个研究中观察到15名患者，将进行中期分析 4周组。组间配对和非配对数据分析将 在统计员的协助下进行。