ESTABLISHMENT OF AIDS TREATMENT EVALUATION UNIT

这份合同是根据单一建议书征集的一系列合同之一。 旨在建立一系列临床研究设施， 将有能力进行第一阶段和第二阶段的临床 对感染艾滋病毒(人类免疫缺陷病毒)患者的研究。 这些研究对于NIAID来说是必要的，以确定安全并可能 针对这种感染的有效治疗方案。这些研究将提供 此外，关于所评价药物的药代动力学的信息 以及他们的代谢产物。承包商将负责评估 患者的反应治疗使用性能状态、药物反应、 药代动力学分析，以及预先指定的毒性标准。这个 承包商将负责从 各种临床样本，用于评估之前的免疫状态， 在治疗期间和治疗后，并进行深入的药代动力学 对部分接受治疗的患者进行了分析。患者的临床状况 将会受到定期监测。数据将通过远程录入提交到 集中协调中心。调查人员将定期与 艾滋病药物选择委员会讨论当前和未来的研究和 通过有重点的研讨会解决技术问题。 合同还包括B部分，其中包含一项类似的声明 作为A部分的工作，但针对机会主义者的临床研究 传染性疾病常见于艾滋病患者。

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.