LC: HIV PREVENTION TRIALS NETWORK

LC：艾滋病毒预防试验网络

基本信息

批准号：
10536592
负责人：
SUSAN H ESHLEMAN
金额：
$ 697.42万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-06-01 至 2027-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10536592
关键词：
AIDS prevention Address Adolescent Africa Ancillary Study Anti-Retroviral Agents Area Asia Award Behavior Therapy Behavioral Biological Assay Biomedical Research Clinical Clinical Trials Clinical Trials Network Cohort Studies Collaborations Communities Couples Data Development Discipline Drug Delivery Systems Eastern Europe Ensure Epidemic Evaluation Generations Goals Government HIV HIV prevention trial HIV prevention trials network HIV/AIDS Human immunodeficiency virus test Immunology Individual Infrastructure Injecting drug user Institution International Intervention Investigational New Drug Application Laboratories Laboratory Procedures Laboratory Scientists Latin America Lead Leadership Medical Mentors Methods Mission Observational Study Participant Passive Immunization Pathogenesis Pathologist Performance Persons Pharmaceutical Preparations Pharmacology Phase Play Population Heterogeneity Populations at Risk Positioning Attribute Prevention Research Prevention strategy Protocols documentation Psychological Transfer Quality Control Regulatory Affairs Research Research Personnel Risk Role Science Shapes Site Social Behavior Specialist System Technology Technology Transfer Toxicology United States United States Food and Drug Administration Validation Woman Work assay development co-infection cohort design experience industry partner innovation insight laboratory equipment laboratory experiment meetings men who have sex with men neutralizing antibody novel novel therapeutics operation point of care testing pre-exposure prophylaxis product development protocol development quality assurance research and development research clinical testing response study population transgender women transmission process trial enrollment vaccination strategy virology working group

AIDS prevention Address Adolescent Africa Ancillary Study Anti-Retroviral Agents Area Asia Award Behavior Therapy Behavioral Biological Assay Biomedical Research Clinical Clinical Trials Clinical Trials Network Cohort Studies Collaborations Communities Couples Data Development Discipline Drug Delivery Systems Eastern Europe Ensure Epidemic Evaluation Generations Goals Government HIV HIV prevention trial HIV prevention trials network HIV/AIDS Human immunodeficiency virus test Immunology Individual Infrastructure Injecting drug user Institution International Intervention Investigational New Drug Application Laboratories Laboratory Procedures Laboratory Scientists Latin America Lead Leadership Medical Mentors Methods Mission Observational Study Participant Passive Immunization Pathogenesis Pathologist Performance Persons Pharmaceutical Preparations Pharmacology Phase Play Population Heterogeneity Populations at Risk Positioning Attribute Prevention Research Prevention strategy Protocols documentation Psychological Transfer Quality Control Regulatory Affairs Research Research Personnel Risk Role Science Shapes Site Social Behavior Specialist System Technology Technology Transfer Toxicology United States United States Food and Drug Administration Validation Woman Work assay development co-infection cohort design experience industry partner innovation insight laboratory equipment laboratory experiment meetings men who have sex with men neutralizing antibody novel novel therapeutics operation point of care testing pre-exposure prophylaxis product development protocol development quality assurance research and development research clinical testing response study population transgender women transmission process trial enrollment vaccination strategy virology working group

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项目摘要

PROJECT SUMMARY With 20 years of experience and an outstanding record of performance, the HIV Prevention Trials Network (HPTN) Laboratory Center (LC) is optimally positioned to support the HPTN in 2020 and beyond. As part of the HPTN leadership group, the HPTN LC will help shape the network’s scientific agenda. The HPTN LC will oversee laboratory activities at study sites; perform Quality Assurance/Quality Control (QA/QC) and specialized testing for HPTN protocols; evaluate and validate assays for use in HPTN studies; develop novel assays to achieve study objectives; and perform ancillary studies related to HIV prevention. The HPTN LC has an Administrative Core, a Protocol Operations Core, and five laboratory Cores (Virology, Pharmacology, Co-Infections, Toxicology, Immunology). The HPTN LC also has an Early Product Development Working Group and a working group for Point-of-Care Testing and Remote Technologies. The HPTN LC has extensive experience supporting HIV protocols in the United States (US), Latin America, Africa, and Asia, with recent work in Eastern Europe. The HPTN LC includes seven Protocol Specialists with >100 combined years of experience supporting HPTN studies. The HPTN LC has led efforts to harmonize laboratory procedures across other networks and groups, and collaborates extensively with academic, government, and industry partners. The HPTN LC has supported protocols evaluating biomedical, behavioral, and structural interventions for HIV prevention, often delivered in combination in a wide range of settings and venues. This includes vanguard studies, observational studies, and Phase 1, 2, and 3 clinical trials, with interventions delivered to HIV-uninfected individuals, HIV-infected individuals, couples, cohorts, and communities. HPTN study populations include adolescents, women, men who have sex with men, transgender women, persons who inject drugs, and other groups at risk, with some trials enrolling >40,000 participants. The HPTN LC has performed numerous studies under Investigational New Drug (IND) applications for the US Food and Drug Administration. The HPTN LC’s Quality Management Team includes a Regulatory Affairs Officer who will ensure compliance with institutional, state, federal, and other regulatory requirements. Under the new award, the HPTN will evaluate new products for HIV pre-exposure prophylaxis, including new drugs, new drug delivery systems, multipurpose technologies, and broadly neutralizing antibodies; the HPTN will also perform integrated strategy studies that combine biomedical and socio-behavioral interventions for HIV prevention. The Specific Aims of the HPTN LC are: Aim 1: To provide leadership, expertise, and laboratory support to the HPTN; Aim 2: To support site laboratories and ensure the quality of HPTN laboratory results; and Aim 3: To advance HIV prevention science through assay development and biomedical research. A strong and effective HPTN LC is particularly important in the HPTN because of the vast international scope, diversity, and complexity of HIV prevention trials. This award will enable the HPTN to continue its mission to identify effective strategies for HIV prevention that will help end the HIV/AIDS epidemic.

项目摘要艾滋病毒预防试验网络具有20年的经验和出色的绩效记录（HPTN）实验室中心（LC）在2020年及以后的HPTN方面具有最佳位置。作为一部分 HPTN领导力小组HPTN LC将帮助塑造网络的科学议程。 HPTN LC将监督研究地点的实验室活动；执行质量保证/质量控制（QA/QC）和专业测试用于HPTN协议；评估和验证用于HPTN研究的测定；开发新颖的测定以实现研究目标；并进行与HIV预防有关的辅助研究。 HPTN LC具有行政核心，协议操作核心和五个实验室核心（病毒学，药理学，共同感染，毒理学，免疫学）。 HPTN LC还设有一个早期的产品开发工作组和一个工作组护理点测试和远程技术。 HPTN LC具有支持HIV的丰富经验美国，拉丁美洲，非洲和亚洲的协议最近在东欧进行了工作。这 HPTN LC包括七个协议专家，拥有> 100年的支持HPTN研究的经验。 HPTN LC一直努力协调其他网络和团体的实验室程序，以及与学术，政府和行业合作伙伴广泛合作。 HPTN LC支持评估预防艾滋病毒的生物医学，行为和结构干预措施的方案，通常是在在各种环境和场地中的组合。这包括先锋研究，观察性研究和第1、2和3阶段的临床试验，并提供了艾滋病毒未感染的个体的干预措施，HIV感染了个人，夫妻，人群和社区。 HPTN研究人群包括青少年，女性，男性与男性，跨性别妇女，注入毒品的人和其他有危险的人发生性关系，并进行一些试验注册> 40,000名参与者。 HPTN LC在研究新药下进行了大量研究（IND）美国食品和药物管理局的申请。 HPTN LC的质量管理团队包括监管事务官员将确保遵守机构，州，联邦和其他监管要求。根据新奖，HPTN将评估艾滋病毒预防前预防的新产品，包括新药，新药输送系统，多功能技术以及广泛中和抗体； HPTN还将进行结合生物医学和社会行为的综合策略研究预防艾滋病毒的干预措施。 HPTN LC的具体目的是：目标1：提供领导，专业知识，和实验室支持HPTN；目标2：支持现场实验室并确保HPTN的质量实验室结果；目标3：通过测定开发和生物医学来推进预防艾滋病毒科学研究。强大而有效的HPTN LC在HPTN中尤为重要，因为庞大的国际艾滋病毒预防试验的范围，多样性和复杂性。该奖项将使HPTN能够继续其任务确定预防艾滋病毒的有效策略，有助于结束艾滋病毒/艾滋病流行病。