LONGITUDINAL STUDY OF OCULAR COMPLICATIONS OF AIDS

艾滋病眼部并发症的纵向研究

• 批准号: 7378361
• 负责人: MURK-HEIN HEINEMANN
• 金额: $ 34.01万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378361
• 关键词: LONGITUDINAL; STUDY; OCULAR; COMPLICATIONS; AIDS

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 (LSOCA) is a multi-center prospective, observational study of patients with AIDS. Patients with a diagnosis of AIDS according to the 1993 CDC criteria, with or without ocular complications, will be enrolled. The objectives of the study are: 1) to monitor secular trends in the incidence of ocular complications of AIDS; 2) to determine the effect of HAART-induced changes in immune status on the incidence and course of ocular complications of AIDS; 3) to determine the characteristics of patients that place them at high risk for ocular complications; and 4) to evaluate the effects of treatments for CMV retinitis 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. For patients with a major ocular complication, all follow-up visits will be clinic visits. For patients without a major ocular complication, follow-up visits 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 collection of plasma and blood cells for banking. Banked specimens will be analyzed for HIV RNA levels and CMV DNA levels. Outcomes of primary interest are incidence of CMV retinitis, incidence of other ocular complications and mortality. Other outcomes of interest include incidence of extra-ocular CMV disease, sequelae of AIDS-related eye disease ( e.g., retinal detachment), visual function, quality of life, and incidence of complications of therapies for ocular complications.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。艾滋病眼部并发症的纵向研究（LSOCA）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，有或没有眼部并发症，将被招募。本研究的目的是：1）监测AIDS眼部并发症发病率的长期趋势; 2）确定HAART诱导的免疫状态变化对AIDS眼部并发症发病率和病程的影响; 3）确定使患者处于眼部并发症高危状态的患者特征;评价CMV视网膜炎及其他眼部并发症的治疗对视功能、生活质量和生存的影响。 本研究将入组约2，000例患者。基线时CMV视网膜炎患者的入组将在300至600名患者之间。所有患者将接受3个月随访。对于有严重眼部并发症的患者，所有随访访视均为门诊访视。对于无严重眼部并发症的患者，随访访视将在电话随访访视和诊所随访访视之间交替进行。将从眼部检查、眼底照片、视功能检查、病史、生活质量评估、实验室研究以及采集血浆和血细胞用于建库中收集数据。将分析库存标本的HIV RNA水平和CMV DNA水平。主要关注的结局是CMV视网膜炎的发生率、其他眼部并发症的发生率和死亡率。其他感兴趣的结果包括眼外CMV疾病的发生率、艾滋病相关眼病的后遗症（例如，视网膜脱离）、视觉功能、生活质量和眼部并发症治疗的并发症发生率。