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.

西雅图原发感染项目 (SeaPIP) 临床队列核心 B 的目的是提供 急性 HIV-1 感染患者的特征明确的队列，对这些患者进行纵向随访 标准化方式，解决项目 1-3 中概述的病毒学和免疫学问题。这 受试者的标本，包括通过以下方式获得的血浆、血清、外周血单核细胞 白细胞分离术、从诱导痰收集中获得的肺泡巨噬细胞、生殖器 分泌物和直肠活检将用于表征病毒学、免疫学和临床特征 使用或不使用高效抗逆转录病毒治疗 (HAART) 的急性 HIV-1 感染的结果。病人 核心 B 的招募和后续工作将在华盛顿大学原发感染诊所 (PIC) 进行。 所有 PIC 参与者都参加前瞻性观察研究（方案 002），也可以共同参加一项 HAART治疗研究（方案001）。 核心 B 的具体目标是： 1) 每年识别、积累并保留 10 名急性 HIV-1 感染患者； 2) 维持对先前纳入急性 HIV-1 队列的 25 名高优先级患者的随访 感染以确定其长期病毒学和免疫学特征；和 3) 在 SeaPIP 内并与 HIV-1 合作，设计、实施、完成并报告急性 HIV-1 发病机制和治疗的高质量、最先进的临床研究结果急性感染和早期疾病研究计划（AIEDRP）。 为了实现这些目标，PIC 将制定积极的外展和招募计划，并招募反映西雅图 HIV-1 感染患者情况的患者群体。经验丰富的工作人员将遵循既定的数据收集和管理程序，遵守有关临床研究的所有联邦和地方法规，并通过我们的社区咨询委员会和社区保持与社区的联系。 外展工作。