Clinical Cohort

临床队列

• 批准号: 7952794
• 负责人: Ann Cornwall Collier
• 金额: $ 12.5万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-22 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952794
• 关键词: Acute; Address; Alveolar Macrophages; Arts; Biohazardous Substance; Biopsy; Characteristics; Clinic; Clinical; Clinical Research; Clinical Research Protocols; Collaborations; Collection; Communities; Data Collection; Disease; Enrollment; Goals; HIV Infections; HIV-1; Highly Active Antiretroviral Therapy; Immunologics; Immunology; Individual; Infection; Leukapheresis; Lung; Monitoring Clinical Trials; National Institute of Allergy and Infectious Disease; Observational Study; Outcome; Pathogenesis; Patient Recruitments; Patients; Peripheral Blood Mononuclear Cell; Plasma; Procedures; Protocols documentation; Regulation; Reporting; Research; Research Personnel; Specimen; Sputum; Universities; Washington; cohort; design; experience; follow-up; genital secretion; human subject protection; outreach; patient population; programs; prospective; rectal; research study; therapy design; virology

The purpose of Core B, the Clinical Cohort of the Seattle Primary Infection Program (SeaPIP), is to provide a well-characterized cohort of patients with acute HIV-1 infection, who are followed longitudinally in a standardized manner, to address the virologic and immunologic questions outlined in Projects 1-3. The specimens from subjects, including plasma, serum, peripheral blood mononuclear cells obtained via leukapheresis, pulmonary alveolar macrophages obtained from induced sputum collection, genital secretions, and rectal biopsies will be used to characterize the virological, immunological, and clinical outcomes of acute HIV-1 infection with and without highly active antiretroviral therapy (HAART). Patient recruitment and follow-up for Core B will occur at the University of Washington Primary Infection Clinic (PIC). All PIC enrollees enter a prospective observational study (Protocol 002), and may also co-enroll in a treatment study of HAART (Protocol 001). The Specific Aims of Core B are to: 1) Identify, accrue, and retain 10 patients/year with acute HIV-1 infection; 2) Maintain follow-up of 25 high priority patients previously enrolled into the cohort with acute HIV-1 infection to characterize their long-term virological and immunological characteristics; and 3) Design, implement, complete, and report the results of high-quality, state-of-the-art clinical research studies of pathogenesis and treatment of acute-HIV-1, both within the SeaPIP and in collaboration with the HIV-1 Acute Infection and Early Disease Research Program (AIEDRP). To accomplish these goals, the PIC will have an active outreach and recruitment plan and enroll a patient population that is reflective of patients in Seattle acquiring HIV-1 infection. The experienced staff will follow established procedures for data collection and management, comply with all federal and local regulations about clinical studies, and maintain linkages with the community via our Community Advisory Board and outreach efforts.

西雅图初级感染计划(SeaPIP)的临床队列核心B的目的是提供 具有良好特征的急性HIV-1感染患者队列，他们在纵向上接受了 以标准化方式处理项目1-3中概述的病毒学和免疫学问题。这个 受试者样本，包括通过以下途径获得的血浆、血清、外周血单核细胞 白细胞分离术，从诱导痰中获得的肺泡巨噬细胞，生殖器 分泌物和直肠活检将用于病毒学、免疫学和临床特征。 接受和不接受高效抗逆转录病毒治疗(HAART)的急性HIV-1感染的结果。有耐心的 核心B的招募和后续工作将在华盛顿大学初级感染诊所(PIC)进行。 所有PIC参与者都可以参加一项前瞻性观察性研究(《002议定书》)，也可以共同参加 HAART的治疗研究(001方案)。 核心B的具体目标是： 1)识别、累积和保留每年10名急性HIV-1感染患者； 2)对先前登记在队列中的25名感染急性艾滋病毒-1的高优先级患者进行随访 确定其长期病毒学和免疫学特征； 3)在SeaPIP内部和与HIV-1急性感染和早期疾病研究计划(AIEDRP)合作，设计、实施、完成和报告关于急性HIV-1发病机制和治疗的高质量、最先进的临床研究的结果。 为了实现这些目标，PIC将有一个积极的外展和招募计划，并招募反映西雅图感染HIV-1患者的患者群体。经验丰富的工作人员将遵循既定的数据收集和管理程序，遵守所有关于临床研究的联邦和地方法规，并通过我们的社区咨询委员会和 外展工作。