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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 艾滋病眼部并发症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年美国疾病控制与预防中心的诊断标准，有或没有眼部并发症的艾滋病患者被纳入研究对象。目标是：1)监测艾滋病眼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艾滋病眼并发症发生率和病程的影响；3)确定使他们处于眼并发症高危状态的患者的特征；以及4)评估CMV视网膜炎治疗和其他眼并发症对视觉功能、生活质量和生存的影响。 约2,000名患者将参加这项研究。基线的巨细胞病毒性视网膜炎患者登记人数将在300至600人之间。所有患者都将接受为期3个月的随访。有严重眼部并发症的患者将进行临床随访。没有严重眼部并发症的患者将在电话随访和诊所随访之间交替进行。数据将从眼睛检查、眼底照片、视觉功能测试、病史、生活质量评估、实验室研究以及为银行收集血浆和血细胞而收集。将对储存的样本进行HIV RNA水平和CMV DNA水平的分析。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。其他令人感兴趣的结果包括眼外巨细胞病毒病的发生率和眼部并发症治疗的并发症、艾滋病相关眼病(例如视网膜脱离)的后遗症、视觉功能和生活质量。