METHADONE QD WITH FOSAMPRENAVIR

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项开放标签研究，旨在观察福沙那韦700 mg BID +利托那韦100 mg BID对接受美沙酮维持治疗的受试者的美沙酮血液水平和美沙酮效应的联合作用。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维持治疗，他们的艾滋病毒感染将接受FPV和RTV治疗。我们需要了解这些药物之间可能的相互作用。将入组参加经认证的美沙酮维持治疗计划至少12周且在接受研究药物前已维持稳定美沙酮QD给药方案30天的HIV血清阴性受试者。 受试者将于第1阶段第1-4天在研究中心接受美沙酮QD治疗。 受试者将在第1阶段第4天美沙酮给药前后接受系列血浆PK采样和阿片类药物PD测量。 采集最后24小时血浆美沙酮PK样本后，开始第2阶段。 在第2阶段第1天，受试者将开始美沙酮QD联合FPV 700 mg BID + RTV 100 mg BID给药，并将继续该方案直至第2阶段第14天。 受试者将在第2阶段第14天接受连续血浆PK采样，并在第2阶段第7天和第14天接受阿片类药物PD测量。 在整个研究期间，将通过不良事件、合并用药、临床实验室检查和生命体征评估来评估安全性。 受试者将在停用研究药物后14-21天返回诊所接受随访访视。

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.