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: 6117838
• 负责人: JOSEPH WHEAT
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6117838
• 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

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 siginficance of HIV- up-regulation due to GM-CSF in a patient population receiving antiretroviral therapy.

主要目的是比较机会性 晚期HIV感染患者中GM-CSF或安慰剂的感染 在标准抗逆转录病毒治疗的背景下。 第二个目标是比较新发或复发艾滋病的时间- 相关临床事件，包括机会性感染和 恶性肿瘤;比较生存期;比较药物经济学和质量 生命参数;以确定发生和临床 在患者人群中GM-CSF引起HIV上调的意义 接受抗逆转录病毒治疗