THE ESTABLISHMENT OF AIDS TREATMENT EVALUATION UNITS

艾滋病治疗评估单位的建立

• 批准号: 3595957
• 负责人: HENRY H BALFOUR
• 金额: $ 117.59万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 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/3595957
• 关键词: AIDS; cell sorting; combination chemotherapy; dosage; drug administration rate /duration; drug adverse effect; drug metabolism; drug screening /evaluation; human immunodeficiency virus 1; human subject; human therapy evaluation; humoral immunity; immunologic skin test; immunopathology chemotherapy; neoplasm /cancer classification /staging; nuclear medicine; pharmacokinetics; secondary infection; virus classification

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.

该合同是根据单一招标招标的众多合同之一