ESTABLISHMENT OF AIDS TREATMENT EVALUATION UNITS

建立艾滋病治疗评估单位

• 批准号: 3595325
• 负责人: MARTIN S HIRSCH
• 金额: $ 163.42万
• 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/3595325
• 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.

该合同是在一个单一的招标书下征求的多个奖项之一 旨在建立一些临床研究设施， 将有能力进行1期和2期临床试验， 艾滋病病毒（人类免疫缺陷病毒）感染者的研究。 这些研究是必要的NIAID，以确定一个安全的， 有效的治疗方案。 这些研究将提供 此外，评价药物的药代动力学信息 及其代谢物。 承包商将负责评估 患者的反应治疗使用性能状态，药物反应， 药代动力学测定和预先指定的毒性标准。 的 承包商将负责进行病毒分离分析， 各种临床样本，用于评估免疫状态之前， 治疗期间和治疗后，以及进行深入的药代动力学研究 对接受治疗的患者子集进行分析。 患者的临床状态 将定期监测。 数据将通过远程输入提交给 中央协调中心。 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， 通过专题研讨会解决技术问题。 该合同还包括一个B部分，其中包括一个类似的声明 作为A部分的工作，但针对机会性的临床研究， 传染性常见于艾滋病患者。