课题基金 / 基金详情

PHASE II PLACEBO CONTROLLED TRIAL OF RECOMBINANT HUMAN GM CSF

PHASE II PLACEBO CONTROLLED TRIAL OF RECOMBINANT HUMAN GM CSF
重组人类 GM CSF 的 II 期安慰剂对照试验
批准号：
6291175
负责人：
JOSEPH WHEAT
金额：
$0.04万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6291175
关键词：
HIV infections antiviral agents clinical research colony stimulating factor drug screening /evaluation health economics human morbidity human mortality human subject human therapy evaluation opportunistic infections pathologic process placebos quality of life

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中文摘要
翻译
主要目的是比较GM-CSF或安慰剂在晚期HIV感染患者中机会性感染的发生率与标准抗逆转录病毒治疗的背景。第二个目标是比较新的或复发的艾滋病相关临床事件的时间，包括机会性感染和恶性肿瘤；比较存活率；比较药物经济学和生活质量参数；确定在接受抗逆转录病毒治疗的患者中由于GM-CSF导致艾滋病毒上调的发生情况和临床意义。
英文摘要
The primary objective is to compare the incidence of opportunistic infections with GM-CSF or placebo in patients with advanced HIV infection against a background of standard antiretroviral therapy. The secondary objective is to compare the time to new or recurrent AIDS-related clinical events including opportunistic infections and malignancies; to compare survival; to compare pharmacoeconomic and quality of life parameters; to determine the occurrence of and clinical significance of HIV upregulation due to GM-CSF in a patient population receiving antiretroviral therapy.
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