Clinical Core

临床核心：临床核心将招募和跟踪组成四个项目的所有受试者 这是P01奖助金。临床核心将建立在一个非常成功的早期艾滋病毒感染研究计划的基础上， 加州大学旧金山分校选项项目，自1996年成立以来一直由赫克特博士领导，构成了 为拟议的研究提供特别资源。备选方案项目也确立了成功的方法 招募新感染者的潜在源头伙伴，并已确定40多对伙伴 确认了连锁的系统发育证据。临床核心项目还将纳入一个原发感染队列 在巴西南部的Caxias do Sol，将有重点地招募最近感染艾滋病毒的人 能够确定潜在来源合作伙伴的人员。巴西的这个地区有艾滋病毒感染，在那里 是B和C亚型病毒相似频率的混合物，为比较这些病毒提供了资源 研究项目中重要的艾滋病毒亚型。临床核心将负责招聘和 艾滋病病毒感染者持续时间不到6个月的这项补助金。在旧金山，我们致力于 每年招募50人和30个潜在的艾滋病毒初始传播源伙伴。在卡西亚斯呢？ SOL，我们的目标是每年招募25名最近感染的人，以及25名潜在的源合作伙伴。潜力 将使用系统发育测序对来源伙伴进行评估，以确定可能的来源伙伴。跟进 将对符合本提案中项目的关键标准的受试者进行测试。核心将获得 用于研究项目的生物标本，并根据需要进行加工和存储。它还将聚集 每个项目将使用的临床数据，包括临床状态和核心实验室数据，如 随着病毒载量和CD4T细胞的计数。临床核心中心将利用加州大学旧金山分校-GIVI艾滋病研究中心 (CFAR)资源，以提供关于参与者的更专门的实验室数据，这些数据将用于 项目，包括耐药基因分型(CFAR核心病毒学实验室)和免疫分型 激活标记物(CFAR核心免疫学实验室)。样品的加工和超低温保存 UCSF将由UCSF-CFAR艾滋病标本库进行测试，该库在以下方面具有丰富的经验 为艾滋病毒研究处理和存储生物标本。巴西部分将建立在 建立艾滋病毒相关队列研究的基础设施，并纳入病毒学和免疫学专家 圣保罗联邦大学医学院的实验室。临床资料和生物标本 由临床核心产生也将成为一个重要的研究资源的研究人员在和 加州大学旧金山分校以外的地方。

CLINICAL CORE: The Clinical Core will recruit and follow all the subjects for the four projects that compose this P01 grant. The Clinical Core will build on a very successful research program on early HIV infection, the UCSF Options Project, which has been led by Dr. Hecht since its inception in 1996 and constitutes an exceptional resource for the proposed studies. The Options Project has also established successful methods for recruiting potential source partners of newly infected persons and has identified over 40 partner pairs with confirmed phylogenetic evidence of linkage. The Clinical core will also incorporate a primary infection cohort in Caxias do Sol, located in southern Brazil, which will provide focused recruitment of recently HIV infected persons who can identify potential source partners. This region of Brazil has an HIV infection in which there is a mixture of similar frequencies of subtype B and C virus, offering a resource for comparing these important HIV subtypes in the research projects. The Clinical Core will be responsible for recruiting and following persons with HIV infection of less than 6 months' duration for this grant. In San Francisco, we aim to enroll 50 persons per year, and 30 potential source partners for initial transmission of HIV. In Caxias do Sol, we aim to enroll 25 recently infected persons per year, and 25 potential source partners. Potential source partners will be evaluated using phylogenetic sequencing to identify likely source partners. Follow-up will be performed on subjects who meet key criteria for the projects in this proposal. The core will obtain biological specimens for the research projects and process and store them as needed. It will also gather clinical data that will be used by each of the projects, including clinical status, and core laboratory data such as viral load and CD4 T cell counts. The Clinical Core will leverage UCSF-GIVI Center for AIDS Research (CFAR) resources to provide more specialized laboratory data on participants that will be used across projects, including resistance genotyping (CFAR Core Virology Laboratory) and immunophenotyping for activation markers (CFAR Core Immunology Laboratory). Specimen processing and cryopreservation at UCSF will be performed by the UCSF-CFAR AIDS Specimen Bank, which has extensive experience in processing and storing biological specimens for HIV studies. The Brazil component will build on an established infrastructure for HIV related cohort studies, and incorporate expert virology and immunology labs at the Federal University Medical School in Sao Paulo. The clinical data and biological specimens generated by the Clinical Core will also form an important research resource for investigators within and outside of UCSF.