LONGITUDINAL STUDY OF OCULAR COMPLICATIONS OF AIDS

艾滋病眼部并发症的纵向研究

• 批准号: 7604151
• 负责人: MURK-HEIN HEINEMANN
• 金额: $ 3.71万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604151
• 关键词: AIDS diagnosis; Acquired Immunodeficiency Syndrome; Centers for Disease Control and Prevention (U.S.); Characteristics; Clinic; Clinic Visits; Collection; Complication; Computer Retrieval of Information on Scientific Projects Database; Cytomegalovirus; Cytomegalovirus Retinitis; DNA; Data; Disease; Enrollment; Eye diseases; Funding; Fundus; Grant; HIV; Immune; Incidence; Institution; Laboratory Study; Longitudinal Studies; Medical History; Monitor; Observational Study; Ophthalmic examination and evaluation; Outcome; Patients; Plasma Cells; Quality of life; Quality-of-Life Assessment; RNA; Research; Research Personnel; Resources; Retinal Detachment; Risk; Schedule; Source; Specimen; Telephone; Testing; United States National Institutes of Health; Vision; Visit; follow-up; interest; mortality; prospective; trend

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Longitudinal Study of Ocular Complications of AIDS is a multicenter prospective, observational study of patients with AIDS. Patients with an AIDS diagnosis according to 1993 CDC criteria, with or without ocular complications, are enrolled. Objectives are to: 1) monitor secular trends in the incidence of ocular complications of AIDS; 2) determine the effect of HAART-induced changes in immune status on the incidence and course of ocular complications of AIDS; 3) determine characteristics of patients that place them at high risk for ocular complications; and 4) evaluate effects of CMV retinitis treatments and other ocular complications on visual functions, quality of life and survival. Approximately 2,000 patients will be enrolled in this study. Enrollment of patients with CMV retinitis at baseline will be between 300 and 600 patients. All patients will be on a 3-month follow-up schedule. Patients with a major ocular complication will have clinic follow-up visits. Patients without a major ocular complication will alternate between telephone follow-up visits and clinic follow-up visits. Data will be collected from eye examinations, fundus photographs, visual function testing, medical history, quality of life assessments, laboratory studies and plasma and blood cells collection for banking. Banked specimens will be analyzed for HIV RNA levels and CMV DNA levels. Primary interest outcomes are incidence of CMV retinitis, other ocular complications and mortality. Other outcomes of interest include incidence of extra-ocular CMV disease and complications of therapies for ocular complications, sequelae of AIDS-related eye disease ( e.g., retinal detachment), visual function, and quality of life.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 艾滋病眼部并发症的纵向研究是一项针对艾滋病患者的多中心前瞻性观察性研究。根据 1993 年 CDC 标准诊断为 AIDS 的患者，无论有或没有眼部并发症，均纳入研究。目标是： 1) 监测艾滋病眼部并发症发生率的长期趋势； 2）确定HAART引起的免疫状态变化对AIDS眼部并发症的发生率和病程的影响； 3) 确定导致眼部并发症高风险的患者特征； 4) 评估 CMV 视网膜炎治疗和其他眼部并发症对视觉功能、生活质量和生存的影响。 大约 2,000 名患者将参加这项研究。基线时患有 CMV 视网膜炎的患者入组人数将在 300 至 600 名之间。所有患者都将接受为期 3 个月的随访。患有主要眼部并发症的患者将接受临床随访。没有主要眼部并发症的患者将轮流进行电话随访和诊所随访。数据将从眼科检查、眼底照片、视功能测试、病史、生活质量评估、实验室研究以及血浆和血细胞收集中收集。将对储存的样本进行 HIV RNA 水平和 CMV DNA 水平分析。主要关注的结果是 CMV 视网膜炎的发生率、其他眼部并发症和死亡率。其他感兴趣的结果包括眼外 CMV 疾病的发生率和眼部并发症治疗的并发症、艾滋病相关眼部疾病的后遗症（例如视网膜脱离）、视功能和生活质量。