GANCICLOVIR CIDOFOVIR CMV RETINITIS TRIAL (GCCRT, ACTG 350)

更昔洛韦西多福韦 CMV 视网膜炎试验（GCCRT，ACTG 350）

• 批准号: 6263935
• 负责人: MURK-HEIN HEINEMANN
• 金额: $ 7.95万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 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/6263935
• 关键词: AIDS; AIDS therapy; cidofovir; clinical research; combination therapy; cytomegalovirus retinitis; eye disorder chemotherapy; ganciclovir; human subject; human therapy evaluation; implant; oral administration

This is a study of two treatment regimens that are administered without the use of a central venous catheter for both newly diagnosed and relapsed AIDS-related CMV retinitis. The primary objective of the trial is to compare the newest CMV retinitis drug, cidofovir, to a commonly used treatment regimen, the ganciclovir intraocular device plus oral ganciclovir, with respect to efficacy in preventing vision loss. A secondary objective is to compare a treatment regimen that incorporates highly active local therapy (the ganciclovir device) with a treatment regimen that does not. Progress report and summary of findings: Patients have been recruited since 1997 and there are now a total of 4 active and 1 deceased patient. This phase IV trial is in the process of comparing two FDA approved treatment regimens for CMV Retinitis. The two treatments are: 1) the ganciclovir intraocular implant plus oral ganciclovir and 2) peripherally infused cidofovir.

这是一项针对新诊断和复发的艾滋病相关巨细胞病毒视网膜炎不使用中心静脉导管的两种治疗方案的研究。 该试验的主要目的是比较最新的 CMV 视网膜炎药物西多福韦与常用的治疗方案（更昔洛韦眼内装置加口服更昔洛韦）在预防视力丧失方面的功效。 第二个目标是比较采用高活性局部疗法（更昔洛韦装置）的治疗方案与不采用高活性局部疗法的治疗方案。进展报告和调查结果摘要： 自 1997 年起开始招募患者，目前共有 4 名活跃患者和 1 名死亡患者。这项 IV 期试验正在比较 FDA 批准的两种 CMV 视网膜炎治疗方案。 两种治疗方法是：1）更昔洛韦眼内植入物加口服更昔洛韦和2）外周输注西多福韦。