PHARMACOLOGICAL INTERACTIONS BETWEEN ZIDOVUDINE AND RIBAVIRIN

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。研究类型：干预性研究设计：治疗，非随机，开放标签，非对照，单组分配，药代动力学研究正式名称：齐多夫定和利巴韦林在用Rebetron或Peg-Intron加利巴韦林治疗的HCV-HIV合并感染患者中的药理学相互作用进一步研究详情：预计总入组人数：20研究开始：2000年5月估计波多黎各有50，000人感染HCV。HIV和HCV有相似的传播途径，HCV合并感染发生在8%至23%的HIV感染者中。研究人员已经表明，用Rebetron（利巴韦林加干扰素α-2b）治疗HCV可显著降低HCV病毒载量，而不影响HIV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。需要此类测量为HIV/HCV合并感染患者的给药提供更合理的依据。本研究将研究Rebetron治疗或PEG-内含子（聚乙二醇化干扰素）和利巴韦林治疗前后细胞内暴露于活性ZDV代谢物的情况。本研究中的受试者将继续接受其常规抗逆转录病毒治疗方案;在研究的前4周内，不得对该方案进行任何变更。研究入组后，受试者将接受细胞内药代动力学研究。在第2周期间，参与者将开始Rebetron或PEG-Intron加利巴韦林治疗，将进行细胞内药代动力学研究，并将接受肝活检。将在第12周和第24周进行额外的细胞内药代动力学研究。Rebetron或PEG-Intron加利巴韦林将给予48周。第二次肝活检将在停止Rebetron或PEG-Intron加利巴韦林治疗后24周进行。参与者将被跟踪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.