PHARMACOLOGICAL INTERACTIONS BETWEEN ZIDOVUDINE AND RIBAVIRIN

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。研究类型：干预性研究设计：治疗、非随机、开放标签、非控制、单组分配、药代动力学研究官方标题：在接受Rebetron或Peg-Intron加利巴韦林治疗的丙型肝炎病毒-艾滋病毒混合感染患者中，齐多夫定和利巴韦林之间的药理相互作用进一步研究细节：预计总登记人数：20项研究开始：2000年5月波多黎各估计有5万人感染丙型肝炎病毒。艾滋病毒和丙型肝炎病毒的传播途径相似，8%到23%的艾滋病病毒感染者会同时感染丙型肝炎病毒。研究人员已经证明，使用Rebetron(利巴韦林加干扰素α-2b)治疗丙型肝炎病毒显著降低丙型肝炎病毒载量，而不影响艾滋病毒载量。然而，没有进行齐多夫定活性形式(ZDV-MP和ZDV-TP)的细胞内水平的测量。这样的测量是需要的，以便为艾滋病毒/丙型肝炎混合感染患者提供更合理的剂量基础。这项研究将调查雷贝隆或聚乙二醇化干扰素(聚乙二醇化干扰素)和利巴韦林治疗前后细胞内对ZDV活性代谢物的暴露情况。这项研究的参与者将继续他们通常的抗逆转录病毒方案；在研究的前4周，该方案可能不会改变。进入研究后，参与者将进行细胞内药代动力学研究。在第二周内，参与者将开始接受瑞贝隆或聚乙二醇Intron加利巴韦林治疗，进行细胞内药代动力学研究，并接受肝脏活检。更多的细胞内药代动力学研究将在12周和24周进行。瑞贝隆或聚乙二醇因特隆加利巴韦林的疗程为48周。第二次肝脏活检将在停止雷贝隆或聚乙二醇因特隆加利巴韦林治疗24周后进行。参与者将被跟踪观察72周。

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. Study Type: Interventional Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study Official Title: Pharmacological Interactions Between Zidovudine and Ribavirin in HCV-HIV Co-Infected Patients Treated With Rebetron or Peg-Intron Plus Ribavirin Further Study Details: Expected Total Enrollment: 20 Study start: May 2000 An estimated 50,000 people in Puerto Rico are infected with HCV. HIV and HCV have similar routes of transmission, and HCV co-infection occurs in 8% to 23% of HIV infected patients. Researchers have shown that treatment for HCV with Rebetron (ribavirin plus interferon alfa-2b) significantly decreases HCV viral load without affecting HIV viral load. However, measurements of intracellular levels of the active forms of zidovudine (ZDV-MP and ZDV-TP) were not performed. Such measurements are needed to provide a more rational basis for dosing in HIV/HCV co-infected patients. This study will investigate the intracellular exposure to active ZDV metabolites prior to and after treatment with Rebetron or treatment with PEG-Intron (pegylated interferon) and ribavirin. Participants in this study will remain on their usual antiretroviral regimen; no changes may be made to that regimen for the first 4 weeks of the study. Upon study entry, participants will have intracellular pharmacokinetic studies. During Week 2, participants will start either Rebetron or PEG-Intron plus ribavirin therapy, will have intracellular pharmacokinetic studies, and will undergo liver biopsy. Additional intracellular pharmacokinetic studies will be performed at Weeks 12 and 24. Rebetron or PEG-Intron plus ribavirin will be given for 48 weeks. A second liver biopsy will be performed 24 weeks after discontinuing Rebetron or PEG-Intron plus ribavirin therapy. Participants will be followed for 72 weeks.