HUMAN IMMUNODEFICIENCY VIRUS AND CYTOMEGALOVIRUS VIRAL BURDEN

人类免疫缺陷病毒和巨细胞病毒的病毒负担

• 批准号: 6291011
• 负责人: MICHAEL FRANK
• 金额: $ 1.7万
• 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/6291011
• 关键词: AIDS; CD4 molecule; CD8 molecule; HIV infections; blood chemistry; clinical research; communicable disease diagnosis; cytomegalovirus; cytomegalovirus retinitis; human immunodeficiency virus; human mortality; human subject; longitudinal human study; pathologic process; virus DNA; virus RNA

This is a prospective, multicenter, observational study of HIV-infected subjects who are CMV-seropositive and who have not had clinical symptoms of CMV disease at study entry. Subjects will be followed for three years or until the diagnosis of CMV end-organ disease, or death, whichever comes first. Clinical evaluations will be performed at baseline and every 8 weeks. Blood samples for virologic studies will be obtained every 16 weeks. Blood samples will also be stored every 16 weeks for future immunologic studies. Routine clinical evaluations will be performed prior to enrollment and every 8 weeks for the duration of the study. Ophthalmologic evaluations will be performed at baseline and at 24-week intervals, as well as whenever symptoms indicate a need for a diagnostic evaluation for CMV retinitis. CD4/CD8 counts will be monitored and plasma and polymorphonuclear blood leukocytes will be stored for quantitative HIV RNA and CMV DNA studies at baseline, 16-week intervals, and whenever CMV end- organ disease is diagnosed. Evaluations for non-ocular disease will be performed when clinically indicated and according to predetermined guidelines. Co-enrollment will be permitted in other ACTG studies. This study aims to analyze in detail the relationships between HIV load, CMV load, and CMV end-organ disease in patients with AIDS who are at risk for developing this complication. In addition, the study will describe the natural history of CMV infection in patients receiving a variety of antiretroviral therapies (including HAART), or no anti-HIV therapy at all.

这是一项针对 HIV 感染者的前瞻性、多中心、观察性研究 CMV 血清阳性且没有临床症状的受试者 研究开始时CMV疾病的发生情况。受试者将被跟踪三年 或直到诊断出巨细胞病毒终末器官疾病或死亡，以发生者为准 第一的。临床评估将在基线时进行，并且每 8 次进行一次 几周。每 16 次采集一次用于病毒学研究的血液样本 几周。血液样本也将每 16 周保存一次，以备将来使用 免疫学研究。 常规临床评估将在入组之前进行 在研究期间每 8 周一次。 眼科评估 将在基线和每 24 周的间隔进行一次，以及 每当症状表明需要进行 CMV 诊断评估时 视网膜炎。将监测 CD4/CD8 计数，并监测血浆和 将储存多形核血白细胞以定量 HIV RNA 和 CMV DNA 研究在基线、16 周间隔以及每当 CMV 结束时进行 诊断出器官疾病。 对非眼部疾病的评估将 当有临床指示时并根据预定进行 指导方针。 其他 ACTG 研究将允许共同入组。 本研究旨在详细分析 HIV 载量、 高危艾滋病患者的 CMV 负荷和 CMV 终末器官疾病 为了发展这种并发症。此外，该研究将描述 接受各种治疗的患者 CMV 感染的自然史 抗逆转录病毒治疗（包括HAART），或根本不进行抗HIV治疗。