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: 6279066
• 负责人: MICHAEL FRANK
• 金额: $ 1.68万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6279066
• 关键词: AIDS; CD4 molecule; CD8 molecule; HIV infections; blood chemistry; clinical research; communicable disease diagnosis; cytomegalovirus; eye infections; human immunodeficiency virus; human mortality; human subject; longitudinal human study; pathologic process; retinitis; 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血清阳性且无临床症状的受试者 在研究开始时发现巨细胞病毒病。受试者将被跟踪调查三年 或直到诊断出巨细胞病毒终末器官疾病，或死亡，无论发生什么 第一。临床评估将在基线和每隔8天进行一次 几周。用于病毒学研究的血液样本将每16天采集一次 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选前进行，并 在研究期间每8周一次。眼科评估 将以基线和24周为间隔进行，以及 只要症状表明需要对CMV进行诊断评估 视网膜炎。将监测CD4/CD8计数和血浆和 多形核白细胞将被储存用于定量HIV RNA 和CMV DNA研究，在基线、16周间隔和CMV结束时- 器官疾病被诊断出来。对非眼部疾病的评估将是 在临床指征时并根据预先确定的情况进行 指导方针。其他ACTG研究将允许联合招生。 这项研究旨在详细分析艾滋病病毒载量与 艾滋病高危患者的巨细胞病毒载量和巨细胞病毒终末器官疾病 导致这种并发症的原因。此外，这项研究将描述 接受不同治疗的患者巨细胞病毒感染的自然病史 抗逆转录病毒疗法(包括HAART)，或者根本不抗艾滋病毒疗法。