A PILOT STUDY OF SILYMARIN IN PATIENTS WITH HIV AND HCV

水飞蓟素治疗 HIV 和 HCV 患者的初步研究

• 批准号: 7380557
• 负责人: HENRY S SACKS
• 金额: $ 15.03万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-17 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380557
• 关键词: HIV infections; infection; milk

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. It is well-known that HIV infection is a major cause of morbidity and mortality worldwide. In the developed countries, there have been major advances in the treatment of HIV infection in recent years and most patients are treated with HAART, with significant improvement in symptoms, reduced incidence of opportunistic infections and prolongation of survival, albeit at a high cost, both in dollars and in treatment-associated side effects. Since HCV is also transmitted by blood and body fluids, HCV-coinfection is very common in HIV, with most surveys finding that 40-75% of patients with HIV also have HCV. As treatment and prophylaxis have improved for many opportunistic diseases, HCV is emerging as an increasing problem. HCV co-infection has been shown to affect the progression of HIV, and end-stage liver disease is becoming a common cause of death in patients with HIV. Treatment for HCV has also improved in recent years, but remains expensive, toxic and at best partially effective. In addition, the complexity of most HAART regimens makes the addition of HCV therapy doubly daunting for both patients and providers. Current recommendations for treating HCV in co-infected patients suggest treating for HCV before patients meet criteria for HAART. However, in practice, particularly in poorer inner-city areas, HIV infection is often diagnosed when patients' disease is advanced, and HAART therapy becomes a priority. Since HAART is often hepatotoxic, many providers are reluctant to further complicate matters by adding more drugs, and HCV is often untreated. In fact in our clinic, where 40% of patients with HIV have HCV-coinfection, less than 10% are currently treated for both. The objective of this project is to assess the feasibility of investigating the effect of silymarin, derived from the milk thistle plant, Silybum maranum (L.) Gaertn. in preventing or reversing the complications of chronic infection with hepatitis C virus in patients with 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 coinfected patients and their providers. Hypothesis: Subjects co-infected with HIV and HCV who receive milk thistle in combination with Highly Active Antiretroviral Therapy (HAART) will experience improvement in symptoms of HCV and HIV. Milk thistle will be tolerated and efficacious in this population of patients.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。众所周知，艾滋病毒感染是全世界发病率和死亡率的主要原因。在发达国家，近年来在艾滋病毒感染的治疗方面取得了重大进展，大多数患者接受了HAART治疗，症状显著改善，机会性感染的发生率降低，生存时间延长，尽管代价高昂，无论是在金钱上还是在与治疗相关的副作用方面。由于丙型肝炎病毒也通过血液和体液传播，丙型肝炎病毒合并感染在艾滋病毒中非常常见，大多数调查发现，40%-75%的艾滋病毒患者也感染了丙型肝炎病毒。随着许多机会性疾病的治疗和预防措施的改善，丙型肝炎病毒正在成为一个日益严重的问题。丙型肝炎病毒混合感染已被证明影响艾滋病毒的进展，终末期肝病正成为艾滋病毒患者的常见死亡原因。近年来，丙型肝炎的治疗也有所改善，但仍然昂贵、有毒，充其量也只是部分有效。此外，大多数HAART方案的复杂性使得增加丙型肝炎治疗对患者和提供者来说都加倍令人望而生畏。目前对合并感染患者治疗丙型肝炎病毒的建议建议在患者达到HAART标准之前治疗。然而，在实践中，特别是在较贫穷的市中心地区，艾滋病毒感染往往在患者病情晚期时被诊断出来，HAART治疗成为优先事项。由于HAART通常对肝脏有毒性，许多提供者不愿通过添加更多药物来进一步复杂化问题，而丙型肝炎病毒往往得不到治疗。事实上，在我们的诊所，40%的艾滋病毒患者合并感染丙型肝炎病毒，目前只有不到10%的患者同时接受治疗。本项目的目的是评估研究从水飞蓟植物水飞蓟中提取的水飞蓟素作用的可行性。加尔特恩。在预防或逆转艾滋病毒患者慢性丙型肝炎病毒感染的并发症方面，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有限，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。假设：接受牛奶蓟联合高效抗逆转录病毒治疗(HAART)的同时感染艾滋病毒和丙型肝炎病毒的受试者将体验到丙型肝炎病毒和艾滋病毒症状的改善。在这群患者中，牛奶蓟是可以耐受和有效的。