PHASE III STUDY OF GANCICLOVIR AND RGM-GSF FOR AIDS RELATED CMV RETINITIS

更昔洛韦和 RGM-GSF 治疗艾滋病相关巨细胞病毒视网膜炎的 III 期研究

• 批准号: 3863987
• 负责人: DOUGLAS DIETERICH
• 金额: --
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3863987
• 关键词: AIDS; T lymphocyte; clinical trials; colony stimulating factor; cytomegalovirus; dihydroxypropoxymethylguanine; drug adverse effect; eye disorder chemotherapy; gene expression; human immunodeficiency virus; human subject; human therapy evaluation; leukopenia; retinitis

This study will determine in patients previously intolerant to ganciclovir because of neutropenia whether co-administration of GM-CSF improves tolerance and if this improvement is associated with a favorable clinical outcome, as defined by a delayed time-to-progression of retinitis. It will also assess changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood, and it will confirm the safety of co- administration of ganciclovir and GM-CSF.

这项研究将确定以前对更昔洛韦不耐受的患者 由于中性粒细胞减少症，联合使用GM-CSF是否改善 耐受性，如果这种改善与良好的临床 结果，定义为视网膜炎进展时间延迟。它将 还评估血清中HIV p24抗原表达的变化， 血液中T4+淋巴细胞的数量，它将确认 更昔洛韦和GM-CSF的联合给药。