A PILOT STUDY OF SILYMARIN IN PATIENTS WITH HIV AND HCV

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。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，大多数患者接受了高效抗逆转录病毒疗法治疗，症状明显改善，机会性感染发生率降低，生存期延长，尽管费用高昂，无论是美元还是治疗相关的副作用。由于HCV也通过血液和体液传播，HCV合并感染在HIV中非常常见，大多数调查发现40-75%的HIV患者也患有HCV。随着对许多机会性疾病的治疗和预防的改善，HCV正在成为一个日益严重的问题。HCV合并感染已被证明会影响HIV的进展，终末期肝病正在成为HIV患者死亡的常见原因。近年来，HCV的治疗也有所改善，但仍然昂贵，有毒，最多部分有效。此外，大多数HAART方案的复杂性使得增加HCV治疗对患者和提供者都是双重的。目前对合并感染患者治疗HCV的建议建议是在患者符合HAART标准之前治疗HCV。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诊断出来的，HAART治疗成为优先事项。由于HAART通常具有肝毒性，许多提供者不愿意通过添加更多药物来使问题进一步复杂化，并且HCV通常未经治疗。事实上，在我们的诊所中，40%的HIV患者合并HCV感染，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水飞蓟素的可行性，水飞蓟素来源于牛奶蓟植物，水飞蓟（L.）Gaertn.在预防或逆转HIV患者慢性丙型肝炎病毒感染并发症方面，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。 假设：受试者同时感染HIV和HCV，接受水飞蓟与高效抗逆转录病毒疗法（HAART）联合治疗，将改善HCV和HIV的症状。在该患者人群中，奶蓟将是耐受和有效的。

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.