ACTG379: DISCONTINUATION OF THERAPY FOR CYTOMEGALOVIRUS RETINITIS

ACTG379：停止巨细胞病毒性视网膜炎治疗

• 批准号: 6265137
• 负责人: MICHAEL FRANK
• 金额: $ 0.04万
• 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/6265137
• 关键词: AIDS therapy; HIV infections; clinical research; clinical trial phase I; cytomegalovirus retinitis; eye disorder chemotherapy; human subject; human therapy evaluation; opportunistic infections

This is a prospective study of the discontuation of maintenance therapy for CMV retinitis. Subjects in Groups 1 and 2 with treated and healed non-immediate sight-threatening CMV retinitis will discontinue maintenance therapy for suppression of CMV retinitis. Healed retinitis will be defined as the lack of opacity at the border or the presence of dry hard opacity that is stable or decreasing after multiple visits as interpreted by an experienced ophthalmologist and confirmed by fundus photographs (27). Subjects must have received therapy with any anti-CMV regimen for at least 8 weeks prior to study entry. However, subjects that have received the ganciclovir intraocular implant <7 months prior to study entry are excluded from participation. Subjects must also have either CD4+ counts > 100 cells/mm3 or CD4+ counts between 50-100 cells/mm3 and a > or equal to (200 copies/ml using the Roche Amplicor RT PCR assay) while receiving potent antiretroviral therapy for at least 8 weeks prior to study entry. Subjects (n=25) who meet the eligibility criteria for this study, but who choose to continue to receive maintenance therapy, may also participate in this study. All subjects will be studied longitudinally to evaluate the relationship between reactivation and progression of CMV disease and changes in CMV, DNA, HIV-1 RNA, and CD4+ cell counts.

这是一项关于巨细胞病毒性视网膜炎维持治疗中断的前瞻性研究。第1组和第2组中已治疗和治愈的非立即视力威胁巨细胞病毒性视网膜炎患者将停止维持治疗以抑制巨细胞病毒性视网膜炎。经经验丰富的眼科医生解释并通过眼底照片证实，已愈合的视网膜炎将被定义为边界处没有浑浊或存在干燥的硬浑浊，在多次就诊后稳定或减少。受试者必须在研究开始前接受任何抗巨细胞病毒方案治疗至少8周。然而，在研究开始前小于7个月接受更昔洛韦眼内植入的受试者被排除在外。受试者还必须在研究开始前至少8周接受有效的抗逆转录病毒治疗时，CD4+计数在50-100细胞/mm3之间或CD4+计数在50-100细胞/mm3和>之间或等于（使用罗氏扩增RT PCR检测200拷贝/ml）。符合本研究资格标准但选择继续接受维持治疗的受试者（n=25）也可以参加本研究。所有受试者将进行纵向研究，以评估巨细胞病毒疾病的再激活和进展与巨细胞病毒、DNA、HIV-1 RNA和CD4+细胞计数变化之间的关系。