THE ESTABLISHMENT OF AIDS TREATMENT EVALUATION UNITS

这份合同是根据单一合同征求的一系列合同之一 RFP旨在实施多项临床研究 将有能力执行第一阶段和 HIV感染患者的第二阶段临床研究(人类 免疫缺陷病毒)。这些研究对于NIAID来说是必要的 找出一种安全且可能有效的治疗方案 这种感染。这些研究将提供信息，此外， 被评价药物的药代动力学及其影响因素的研究 代谢物。承包商将负责评估 患者的反应治疗使用性能状态、药物 指定的反应、药代动力学分析和毒性标准 预先。承包商将负责履行 从各种临床样本中进行病毒分离分析，以 在治疗前、治疗中和治疗后评估免疫状态， 并且用于在子集上执行深入的药代动力学分析 接受治疗的患者的比例。患者的临床状态将是 定期监控。数据将通过远程录入提交到 集中协调中心。调查人员将定期会面 与艾滋病药物选择委员会讨论当前和 未来的研究和解决技术问题的重点 研讨会。 合同还包括B部分，该部分由类似的 A部分的工作说明，但针对的是临床研究 在艾滋病患者中常见的机会性感染。

This contract is one of a number of awards solicited under a single RFP designed to put in place a number of clinical research facilities that would have the capability of performing Phase 1 and Phase 2 clinical studies in patients infected with HIV (Human Immunodeficiency virus). These studies are necessary for the NIAID to identify a safe and possibly efficacious treatment regimen for this infection. The studies will provide information, in addition, on the pharmacokinetics of the drugs evaluated and their metabolites. The contractor will be responsible for assessing the patient's response therapy using performance status, drug response, pharmacokinetic assays, and toxicity criteria designated in advance. The contractor will be responsible for performing viral isolation assays from a variety of clinical samples, for evaluating immunologic status prior to, during, and after therapy, and for performing in-depth pharmacokinetic analysis on a subset of patients treated. Clinical status of the patients will be regularly monitored. Data will be submitted by remote entry to a centralized coordinating center. Investigators will meet regularly with the AIDS Drug Selection Committee to discuss current and future studies and resolve technical issues through focused workshops. The contract also includes a Part B which consists of a similar statement of work as Part A but is directed at clinical studies of the opportunistic infectious commonly seen with patients with AIDS.