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: 6117871
• 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/6117871
• 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.

这是一项前瞻性、多中心、观察性研究， CMV血清阳性且无临床症状的受试者 CMV疾病的发病率。受试者将被随访三年 或直至诊断为CMV终末器官疾病或死亡，以发生者为准 先将在基线和每8天进行一次临床评价 周每16天采集一次用于病毒学研究的血液样本。 周血液样本也将每16周储存一次，以备将来使用。 免疫学研究。 将在入组前进行常规临床评价， 在研究期间每8周一次。 眼科评价 将在基线和24周间隔进行，以及 当症状表明需要对CMV进行诊断评估时 视网膜炎将监测CD4/CD8计数，并监测血浆和 将储存多形性血液白细胞用于定量HIV RNA 基线时、16周间隔时和CMV结束时的CMV DNA研究- 诊断出器官疾病。 将对非眼部疾病进行评价 在临床指征时并根据预先确定的 指南 其他ACTG研究将允许联合入组。 本研究旨在详细分析HIV载量、 高危艾滋病患者的巨细胞病毒载量和巨细胞病毒终末器官疾病 导致了这种并发症此外，该研究将描述 接受各种治疗的患者中CMV感染的自然史 抗逆转录病毒治疗（包括HAART），或根本没有抗HIV治疗。