METHADONE QD WITH FOSAMPRENAVIR

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。这是一项开放标签研究，旨在观察福沙普利韦700 mg Bid+利托那韦100 mg Bid对美沙酮血药浓度的联合影响以及美沙酮维持受试者的美沙酮效果。这是一个重要的问题，因为艾滋病毒感染者中的一些人正在接受美沙酮的维持治疗，他们将接受FPV和RTV治疗他们的艾滋病毒感染。我们需要了解这些药物之间可能的相互作用。参加认证美沙酮维持计划至少12周，并在接受研究药物前已接受稳定的美沙酮每日剂量方案维持30天的艾滋病毒血清阴性患者将被登记。受试者将在研究中心接受美沙酮治疗，疗程1-4天。受试者将在服用美沙酮之前和之后的第1天，第4天，进行连续的血浆PK采样和阿片类PD测量。在收集了最后24小时血浆美沙酮PK样本后，第二阶段开始。在第2周期，第1天，受试者将开始服用美沙酮，同时联合FPV 700 mg Bid+RTV 100 mg Bid，并将继续这一方案，直到第2周期，第14天。受试者将在第2周期，第14天接受连续的血浆PK采样，并在第2周期，第7天和第14天接受阿片类PD措施。在整个研究过程中，将通过不良事件、同时用药、临床实验室和生命体征评估来评估安全性。受试者将在停止研究药物14-21天后返回诊所进行随访。

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.