A PILOT STUDY OF SILYMARIN IN PATIENTS WITH HIV AND HCV

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。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，近年来在治疗艾滋病毒感染方面取得了重大进展，大多数患者接受了HAART治疗，症状得到显著改善，机会性感染发生率降低，生存期延长，尽管在美元和治疗相关副作用方面的成本都很高。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%的艾滋病毒患者同时患有丙型肝炎病毒。随着许多机会性疾病的治疗和预防得到改善，丙型肝炎病毒正在成为一个日益严重的问题。丙型肝炎病毒合并感染已被证明会影响艾滋病毒的进展，终末期肝病正在成为艾滋病毒患者死亡的常见原因。近年来，丙型肝炎病毒的治疗也有所改善，但仍然昂贵、有毒，充其量只是部分有效。此外，大多数HAART治疗方案的复杂性使得HCV治疗的增加对患者和提供者来说都是双重的艰巨任务。目前对合并感染患者治疗丙型肝炎的建议是在患者达到HAART治疗标准之前进行治疗。然而，在实践中，特别是在较贫穷的市中心地区，艾滋病毒感染往往是在患者病情进展时才被诊断出来，因此HAART治疗成为优先事项。由于HAART通常是肝毒性的，许多提供者不愿意通过增加更多的药物使问题进一步复杂化，而且HCV通常得不到治疗。事实上，在我们的诊所，40%的艾滋病患者同时感染丙型肝炎病毒，目前只有不到10%的人同时接受治疗。本项目的目的是评估水飞蓟素研究的可行性，水飞蓟素是从水飞蓟植物中提取的。Gaertn。在预防或逆转艾滋病毒患者慢性丙型肝炎病毒感染并发症方面的作用，以作为更明确研究的基础。针对HCV的对抗疗法治疗干预是昂贵且耐受性差的，特别是在美国最常见的基因型。对膳食补充剂水飞蓟的严格评估有限，但有迹象表明，合并感染的患者及其提供者对水飞蓟有益且非常感兴趣。假设：同时感染HIV和HCV的受试者在接受水飞蓟联合高效抗逆转录病毒治疗（HAART）后，HCV和HIV的症状会得到改善。在这类患者中，水飞蓟是耐受性和有效的。

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.