METHADONE QD WITH FOSAMPRENAVIR

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。这是一项开放标签研究，旨在观察福samprenavir 700mg BID +利托那韦100mg BID对美沙酮血液水平的联合影响，以及美沙酮对受试者维持美沙酮的影响。这是一个重要的问题，因为艾滋病毒感染者中有些人正在接受美沙酮维持治疗，他们将接受FPV和RTV治疗。我们需要了解这些药物可能的相互作用。HIV血清阴性受试者参加了经过认证的美沙酮维持计划至少12周，并且在接受研究药物之前已保持稳定的美沙酮QD剂量方案30天。受试者将于第1期第1-4天在研究中心接受美沙酮QD治疗。受试者在给予美沙酮之前和之后的第1期第4天进行连续血浆PK取样和阿片类药物PD测量。收集最后24小时血浆美沙酮PK样本后，开始第二阶段。在第2期，第1天，受试者将开始给药美沙酮QD联合FPV 700mg BID + RTV 100mg BID，并将继续该方案到第2期，第14天。受试者将在第2期、第14天进行连续血浆PK采样，并在第2期、第7天和第14天进行阿片类药物PD测量。在整个研究过程中，安全性将通过不良事件、并发用药、临床实验室和生命体征评估来评估。受试者将在停用研究药物后14-21天返回诊所进行随访。

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. This is an open label study to look at the combined effects of Fosamprenavir 700mg BID + Ritonavir 100mg BID, on blood levels of Methadone and Methadone effects in subjects on Methadone maintenance. This is an important question as HIV infected individuals some of whom are on methadone maintenance, will be treated with FPV and RTV for their HIV infection. We need to understand possible interactions of these medicines. HIV seronegative subjects enrolled in a certified methadone maintenance program for at least 12 weeks and who have been maintained on a stable methadone QD dosage regimen for 30 days prior to receiving study drug will be enrolled. Subjects will receive methadone QD at the study center during Period 1, Days 1-4. Subjects will undergo serial plasma PK sampling and opiate PD measurements on Period 1, Day 4, prior to and following administration of methadone. Following collection of the last 24-hour plasma methadone PK sample, Period 2 begins. On Period 2, Day 1, subjects will initiate dosing of methadone QD in combination with FPV 700mg BID + RTV 100mg BID and will continue this regimen through Period 2, Day 14. Subjects will undergo serial plasma PK sampling on Period 2, Day 14 and opiate PD measures on Period 2, Days 7 and 14. Throughout the study, safety will be assessed through adverse event, concurrent medication, clinical laboratory, and vital signs assessments. Subjects will return to the clinic for a follow-up visit 14-21 days following discontinuation of study drugs.