ESTABLISHMENT OF AIDS TREATMENT EVALUATION UNITS

建立艾滋病治疗评估单位

• 批准号: 3595321
• 负责人: MARTIN S HIRSCH
• 金额: $ 158.81万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-06-30 至 1991-06-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3595321
• 关键词: AIDS; Kaposi's sarcoma; antiAIDS agent; combination chemotherapy; dosage; drug administration routes; drug adverse effect; drug metabolism; human immunodeficiency virus 1; human subject; human therapy evaluation; microorganism disease chemotherapy; microorganism immunology; neoplasm /cancer chemotherapy; tissue /cell culture

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.

该合同是单个RFP征求的许多奖项之一 旨在建立许多临床研究设施 将具有执行第1阶段和第2阶段临床的能力 对感染HIV的患者（人类免疫缺陷病毒）的研究。 这些研究对于NIAID是必要的 该感染的有效治疗方案。 研究将提供 此外，有关评估药物的药代动力学的信息 和他们的代谢产物。 承包商将负责评估 使用性能状况，药物反应，患者的反应疗法， 预先指定的药代动力学测定和毒性标准。 这 承包商将负责从A进行病毒隔离测定 各种临床样本，用于评估免疫状态之前 在治疗期间和治疗后以及进行深入的药代动力学 对接受治疗的患者子集的分析。 患者的临床状况 将定期监视。 数据将通过远程输入提交 集中协调中心。 调查人员将定期开会 艾滋病药物选择委员会讨论当前和未来的研究以及 通过重点研讨会解决技术问题。 合同还包括B部分，该部分由类似的声明组成 作为A部分的工作，但针对机会主义的临床研究 艾滋病患者常见的传染性。