Pilot Trial of Silymarin in Patients with HCV and HIV

描述（由申请人提供）：本项目的目的是评估研究水飞蓟素效果的可行性，水飞蓟素来源于奶蓟植物，水飞蓟（L.）Gaertn.在预防或逆转人类免疫缺陷病毒（HIV）患者慢性丙型肝炎病毒（HCV）感染并发症方面的作用，以作为更明确研究的基础。针对HCV的对抗疗法干预是昂贵的且耐受性差，特别是对于在美国最常见的基因型。对膳食补充剂奶蓟的严格评估有限，但有建议的好处和共同感染患者及其提供者的兴趣。 具体目标：1）收集关于水飞蓟在未接受高效抗逆转录病毒治疗（HAART）的HCV和HIV合并感染患者中的安全性和耐受性的初步信息。2）收集关于水飞蓟在接受高效抗逆转录病毒治疗（HAART）的HCV和HIV合并感染患者中的安全性和耐受性的初步信息。3)收集关于水飞蓟在HCV和HIV合并感染患者中的疗效的初步信息，为更大，更明确的试验做准备。 合并感染的患者将被随机分配接受水飞蓟素或类似的安慰剂。 参与者将从目前在一个大型市中心艾滋病中心登记的HCV感染者中招募。受试者将每天接受研究治疗，持续52周。评估的指标将包括：研究中的保留、研究分配的依从性、自我描述的症状、肝酶水平、病毒载量和清除率、生活质量（SF 36调查）和肝活检（如可用）。据推测，水飞蓟素可以预防肝脏疾病的进展，并可能逆转已经存在的肝脏病变，以及改善生活质量。这个探索性的项目预计将提供数据，以计划更大和更明确的研究对HCV感染的影响，奶蓟。一种廉价和良性的草药膳食补充剂的有益效果的证据将对患有慢性HCV的大量人群产生重大影响。

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.