Pilot Trial of Silymarin in Patients with HCV and HIV

描述(由申请人提供)：本项目的目标是评估从水飞蓟植物水飞蓟中提取的水飞蓟素对水飞蓟素作用的可行性。加尔特恩。在预防或逆转人类免疫缺陷病毒(HIV)患者慢性感染丙型肝炎病毒(HCV)并发症方面的研究，作为更明确的研究的基础。丙型肝炎的对症治疗干预费用昂贵且耐受性差，特别是在美国最常见的基因型别。对膳食补充剂牛奶蓟的严格评估是有限的，但有迹象表明，合并感染的患者和他们的提供者对此有好处和极大的兴趣。具体目标：1)收集关于未接受高效抗逆转录病毒治疗(HAART)的丙型肝炎病毒和艾滋病病毒混合感染患者使用牛奶蓟的安全性和耐受性的初步信息。2)收集正在接受高效抗逆转录病毒治疗(HAART)的丙型肝炎病毒和艾滋病病毒混合感染患者使用水蓟的安全性和耐受性的初步信息。3)收集有关牛奶蓟在丙型肝炎病毒和艾滋病病毒混合感染患者中的疗效的初步信息，为更大规模、更明确的试验做准备。混合感染的患者将被随机分配接受水飞蓟素或类似的安慰剂。参与者将从目前在市中心一家大型艾滋病中心登记的大量丙型肝炎病毒感染者中招募。参与者将在52周内每天接受研究治疗。评估的措施将包括：保留研究、遵守研究任务、自我描述的症状、肝酶水平、病毒载量和清除、生活质量(SF36调查)，以及肝脏活检(如果有)。据推测，水飞蓟素可以预防肝病的进展，并可能逆转已经存在的肝脏病变，以及改善生活质量。这一探索性项目预计将提供数据，以计划更大规模和更明确的水飞蓟对丙型肝炎病毒感染的影响研究。有证据表明，一种廉价、无害的草药膳食补充剂的有益效果将对大批慢性丙型肝炎患者产生重大影响。

DESCRIPTION (provided by applicant): The objective of this project is to assess the feasibility of investigating the effect of silymarin, derived from the milk thistle plant, Silybum marianum (L.) Gaertn. in preventing or reversing the complications of chronic infection with hepatitis C virus (HCV) in patients with human immunodeficiency virus (HIV), to serve as the basis of a more definitive study. Allopathic therapeutic interventions for HCV are expensive and poorly tolerated, particularly with the genotype most commonly encountered in the US. There are limited rigorous assessments of the dietary supplement milk thistle, but there is suggestion of benefit and much interest on the part of co-infected patients and their providers. Specific aims: 1) To collect preliminary information on the safety and tolerability of milk thistle in HCV and HIV co-infected patients who are not on highly active antiretroviral therapy (HAART). 2)To collect preliminary information on the safety and tolerability of milk thistle in HCV and HIV co-infected patients who are on highly active antiretroviral therapy (HAART). 3) To collect preliminary information on the efficacy of milk thistle in HCV and HIV co-infected patients in preparation for a larger, more definitive trial. Co-infected patients will be randomly assigned to receive silymarin or a similar appearing placebo. Participants will be recruited from a large cohort of HCV-infected individuals currently enrolled in a large inner-city AIDS center. Participants will receive the study treatment daily for 52 weeks. Measures to be assessed will include: retention in the study, compliance with study assignment, self-described symptoms, liver enzyme levels, viral load and clearance, and quality of life (SF36 survey), and liver biopsy when available. It is hypothesized that silymarin can prevent progression of liver disease and possibly reverse hepatic lesions that are already present, as well as improve the quality of life. This exploratory project is anticipated to provide data to plan larger and more definitive studies of the effect of milk thistle on HCV infection. Evidence of beneficial effect of an inexpensive and benign herbal dietary supplement would have great impact on the large population suffering from chronic HCV.