ACTG379: DISCONTINUATION OF THERAPY FOR CYTOMEGALOVIRUS RETINITIS

这是一项关于巨细胞病毒视网膜炎维持治疗的破坏性的前瞻性研究。 第1组和第2组中患有经治疗和治愈的非即刻威胁视力的CMV视网膜炎的受试者将停止维持治疗以抑制CMV视网膜炎。治愈的视网膜炎将被定义为边缘不混浊或存在干燥的硬性混浊，经经验丰富的眼科医生解释并经眼底照片证实，在多次就诊后稳定或减少（27）。 受试者必须在进入研究前接受任何抗CMV方案治疗至少8周。然而，在进入研究之前接受更昔洛韦眼内植入物<7个月的受试者被排除在参与之外。 受试者还必须具有CD 4+计数> 100个细胞/mm 3或CD 4+计数在50-100个细胞/mm 3之间并且>或等于（使用Roche Amplicor RT PCR测定法为200拷贝/ml），同时在研究进入之前接受有效的抗逆转录病毒疗法至少8周。符合本研究合格性标准但选择继续接受维持治疗的受试者（n=25）也可参加本研究。 将对所有受试者进行纵向研究，以评价CMV疾病的再激活和进展与CMV、DNA、HIV-1 RNA和CD 4+细胞计数变化之间的关系。

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.