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THE ESTABLISHMENT OF AIDS TREATMENT EVALUATION UNITS

艾滋病治疗评估单位的建立

基本信息

批准号：
3801904
负责人：
HENRY S SACKS
金额：
--
依托单位：
MOUNT SINAI SCHOOL OF MEDICINE OF CUNY
依托单位国家：
美国
项目类别：
财政年份：
1987
资助国家：
美国
起止时间：
1987-01-02 至 1991-06-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/3801904
关键词：
AIDS AIDS therapy Betaherpesvirinae Herpesviridae disease Kaposi's sarcoma Mycobacterium Pneumocystis Pneumocystis pneumonia Toxoplasma antiAIDS agent biotransformation blood cell count clinical chemistry combination chemotherapy communicable disease diagnosis dosage drug adverse effect drug metabolism drug screening /evaluation encephalitis herpes simplex virus 1 herpes simplex virus 2 human immunodeficiency virus 1 human subject human therapy evaluation humoral immunity immunologic skin test lymphoma microorganism disease chemotherapy mycosis neoplasm /cancer neoplasm /cancer classification /staging neoplasm /cancer immunodiagnosis nuclear medicine opportunistic infections pharmacokinetics respiratory infections tissue /cell culture varicella zoster virus virus classification virus replication

项目摘要

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.

该合同是一个单一的招标下的一些奖项之一， RFP旨在实施多项临床研究有能力执行第一阶段的设施， HIV感染患者的II期临床研究（人类免疫缺陷病毒）。这些研究对于NIAID是必要的确定一种安全有效的治疗方案，这种感染。此外，这些研究还将提供信息，评价药物的药代动力学及其代谢物。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、药代动力学试验和指定的毒性标准提前承包商将负责执行从各种临床样品中进行病毒分离测定，在治疗之前、期间和之后评估免疫状态，并对一个子集进行深入的药代动力学分析治疗的病人。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。调查人员将定期开会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，工作坊. 该合同还包括一个B部分，其中包括一个类似的工作说明书作为A部分，但针对以下临床研究：艾滋病患者常见的机会性感染。