Clinical and Data Core

临床和数据核心

基本信息

批准号：
7684934
负责人：
RUTH Martha GREENBLATT
金额：
$ 50.42万
依托单位：
J. DAVID GLADSTONE INSTITUTES
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-01 至 2014-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7684934
关键词：
AIDS prevention Address Age Aging Anti-Retroviral Agents Area Bacterial Vaginosis Blood Blood specimen CD4 Positive T Lymphocytes California Cell physiology Cells Cervical Cessation of life Characteristics Chronic Clinical Clinical Data Clinical Research Collaborations Collection Complex Consent Consultations Contraceptive Agents Contraceptive methods Data Depo Provera Development Distal part of ileum Drug Kinetics Eligibility Determination Endocervix Endometrial Endometrium Enrollment Ensure Female Fresh Tissue Functional disorder Funding Gene Expression Gene Expression Profile Genital system Goals Grant HIV HIV Infections HIV Seropositivity Highly Active Antiretroviral Therapy Hormonal Hour Human Image Immune Immunohistochemistry Immunologics Inflammation Injectable Injury Inpatients Intrauterine Devices Laboratories Link Liquid substance Lymphocyte Count Lymphoid Tissue Mass Spectrum Analysis Measurement Measures Menstrual cycle Methods Mirena Morbidity - disease rate Nucleosides Participant Pathogenesis Persons Pharmaceutical Preparations Pharmacology Phase Phenotype Plasma Postmenopause Predisposition Premenopause Process Progestins Progressive Disease Prophylactic treatment Protocols documentation Recovery Recruitment Activity Regulation Reporting Reproductive Biology Research Research Design Research Personnel Research Project Grants Resources Risk Sampling San Francisco Science Seminal fluid Sigmoid colon Site Specimen Specimen Handling Spermatocidal Agents System Tenofovir Testing Tissue Banks Tissue Sample Tissues Vaginal Spermicides Visit Woman age effect antiretroviral therapy base cohort computerized data processing data management disease phenotype emtricitabine human subject human subject protection immune function immunosenescence in vivo liquid chromatography mass spectroscopy male meetings men microbicide mortality mucosal site nucleoside analog peripheral blood prevent programs reproductive research study response sexually active transmission process truvada vaginal fluid

项目摘要

HIV infection is a major cause of morbidity and mortality among women worldwide. Few of the factors that increase susceptibility of women to HIV infection are known, and the development of woman-controlled HIV prevention methods is slow at best. We propose providing intensive logistical and field support of studies that link reproductive biology, HIV pathogenesis and pharmacology with regards to HIV. The goals of the Clinical and Data Core are to: 1) generate human subjects protocols, recruit, determine eligibility, and retain participants for program studies. 2) collect or obtain data, semen, cervical fluids and brushes, ecto- and endo-cervical and endometrial specimens for program studies according to each project's specifications, 3) measure tenofovir levels within cervical and endometrial tissues in the local Women's Interagency HIV Study (WIHS) participants of the WIHS pharmokinetics research, 4) obtain vaginal fluids from healthy women and women with bacterial vaginosis for studies of semen factors that influence male to female HIV transmission, 5) to interface with WIHS in conducting functional, transcriptome and immunohistochemistry studies of endometrial, ileal and sigmoid colon tissues that will be obtained by WIHS as part of its pathogenesis program. This application proposes a group of highly collaborative research projects that have intersecting data and specimen needs. Offering these resources via a single Core eliminates the need for redundant effort, ensures the efficient distribution of valuable samples, and frees laboratory-based investigators from supervising field activities. To the greatest extent possible use of existing data and specimens will be used, and when new recruitment is needed, we will endeavor to address the needs of multiple studies parsimoniously.

艾滋病毒感染是全球女性发病率和死亡率的主要原因。很少有人知道增加女性对艾滋病毒感染的敏感性的因素，而女性控制的艾滋病毒预防方法的发展充其量是缓慢的。我们提出，为将生殖生物学，HIV发病机理和药理学与HIV联系起来的研究提供密集的后勤和现场支持。临床和数据核心的目标是：1）生成人类主体协议，招募，确定资格并保留参与者进行计划研究。 2）收集或获取数据，精液，宫颈液和刷子，根据每个项目的规格进行程序研究的外节和内颈和子宫内膜标本，3）在当地女性妇女间HIV HIV HIV研究（WIHS）参与的颈椎和子宫内膜组织内的替纳福韦水平，从健康的妇女和细菌性阴道病的妇女到影响男性HIV传播的精液因素的研究，5）到与WIHS进行功能，转录组和免疫组织化学研究，对子宫内膜，肠胃和Sigmoid结肠组织的研究，这些研究将由WIHS作为其发病机制的一部分获得。该应用程序提出了一组高度协作的研究项目，这些项目与数据和标本需求相交。通过单一核心提供这些资源可以消除对冗余努力的需求，确保有价值的样本的有效分配，并为基于实验室的研究人员从监督现场活动中腾出来。最大程度地使用现有数据和标本，当需要新的招聘时，我们将努力解决多个研究的需求简单地。