REPOSITORY SERVICES FOR THE MATERNAL AND PEDIATRIC INFECTIOUS DISEASE BRANCH (MPIDB) SPECIMENS
REPOSITORY SERVICES FOR THE MATERNAL AND PEDIATRIC INFECTIOUS DISEASE BRANCH (MPIDB) SPECIMENS
批准号:
10624174
负责人:
OGUZ MANDACI
金额:
$49.54万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-05-14 至 2023-05-13
关键词:
AIDS/HIV problemAcquired Immunodeficiency SyndromeAdolescentAdolescent Medicine Trials NetworkBar CodesBiological Specimen BanksBrazilChildChildhoodClinical ResearchClinical TrialsClinical Trials NetworkCohort StudiesCommunicable DiseasesContractorContractsDataData Coordinating CenterDoseDrug KineticsElectronic MailEquipment and supply inventoriesExerciseFoundationsFreezingFundingGuidelinesHIVHIV InfectionsHIV therapyHIV-exposed uninfected infantInfantInternationalInternational Maternal Pediatric Adolescent AIDS Clinical TrialsInterventionLaboratoriesManagement Information SystemsMonitorNational Institute of Allergy and Infectious DiseaseNational Institute of Child Health and Human DevelopmentPerformancePoliciesPopulationPregnant WomenProceduresProcessProtocols documentationPublic Health SchoolsResearchResearch ActivitySafetySamplingScienceServicesShippingShipsSiteSpecimenSymptomsSystemTechnologyTeleconferencesTelephoneToxic effectUnited StatesUnited States National Institutes of HealthUpdateVertical Disease TransmissionWomanYouthantiretroviral therapybaseclinical research sitedata managementfrontieroperationpediatric human immunodeficiency virusperinatal HIVpregnantpreventive interventionprogramsrepositorysample collectionyoung woman
中文摘要
母婴传染病科(MPIDB)促进研究,以调查艾滋病毒、其并发症和其他重大传染病对婴儿、儿童、青少年以及怀孕和非怀孕妇女的影响和治疗。这包括主要在两个主要网络进行的签约临床研究活动,这些网络积极收集标本,存放在NICHD储存库中。它们是儿童艾滋病毒艾滋病队列研究(PHACS)和国际母亲、儿童和青少年艾滋病临床试验网络(IMPAACT)。
PHACS是一项总部设在美国的多中心计划,跟踪调查围产期感染艾滋病毒的青年和感染艾滋病毒/未感染艾滋病毒的婴儿、儿童和青年。PHACS目前包括四个主要方案和四个子研究。在18个SMARTT(艾滋病毒感染妇女所生的未感染艾滋病毒的儿童的抗逆转录病毒药物毒性监测研究)和14个需要资料库服务的当前研究地点AMP(青少年主协议)收集了各种类型的标本。
艾滋病毒/艾滋病综合防治网络的重点是评估针对婴儿、儿童、青少年和孕妇的艾滋病毒感染及其相关症状的潜在疗法,包括预防母婴传播的艾滋病毒/艾滋病干预措施的临床试验。研究议程包括对儿童和青少年人群以及孕妇中艾滋病毒/艾滋病的抗逆转录病毒(ARV)新疗法的药代动力学、安全性、最佳剂量和长期并发症的研究。NICHD资助的网站(通过NICHD国际和国内儿科和产妇艾滋病毒研究及其他传染病数据协调中心合同)使用NICHD储存库;NIAID资助的网站使用NIAID支持的单独储存库。NICHD支持的网站还独立或在其他网络内进行其他试验。
IMPAACT网络在14个美国和9个国际NICHD临床研究地点以特定协议收集样本。收集了各种各样的标本类型,需要储存库服务。
PHACS和IMPAACT的数据和操作中心位于哈佛大学公共卫生学院,数据管理服务由前沿科学技术研究基金会(FSTRF)提供。PHACS和IMPAACT都使用前沿科学LDMS实验室信息管理系统来管理他们的样本采集。
艾滋病毒/艾滋病防治中心网络与NICHD国内和国际儿科和产妇艾滋病毒及其他高度优先传染病临床研究网络、青少年医学艾滋病毒/艾滋病干预试验网络以及其他由NICHD、NIH和组织牵头的艾滋病毒/艾滋病研究网络和项目合作。
英文摘要
The Maternal and Pediatric Infectious Disease Branch (MPIDB) promotes research to investigate the impact and treatment of HIV, its complications, and other significant infectious diseases in infants, children, adolescents, and pregnant and nonpregnant women. This includes contracted clinical research activities conducted primarily in two major networks that actively collect specimens to be housed in the NICHD repository. These are the Pediatric HIV AIDS Cohort Study (PHACS) and the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network.
PHACS is a multicenter United States-based program that follows both perinatally HIV-infected youth and HIV-exposed/uninfected infants, children, and youth. PHACS currently includes four main protocols and four sub studies. A wide variety of specimen types are collected at 18 SMARTT (Surveillance Monitoring for ART Toxicities Study in HIV-uninfected Children Born to HIV-infected Women) and 14 AMP (Adolescent Master Protocol) current study sites that require repository services.
The IMPAACT Network is focused on evaluating potential therapies for HIV infection and its related symptoms in infants, children, adolescents, and pregnant women, including clinical trials of HIV/AIDS interventions for prevention of mother-to-child transmission. The research agenda includes studies on the pharmacokinetics, safety, optimal dosing, and long-term complications of new antiretroviral (ARV) therapies for HIV/AIDS in pediatric and adolescent populations and in pregnant women. NICHD-funded sites (via the NICHD International and Domestic Pediatric and Maternal HIV Studies and Other Infectious Diseases Data Coordinating Center contract) utilize the NICHD repository; NIAID-funded sites utilize a separate NIAID-supported repository. NICHD-supported sites also perform other trials independently or within other networks.
The IMPAACT network collects samples in specific protocols at 14 U.S. and 9 international NICHD clinical research sites. A wide variety of specimen types are collected and require repository services.
The Data and Operations Center for both PHACS and IMPAACT is at the Harvard School of Public Health with data management services provided by Frontier Science Technology Research Foundation (FSTRF). Both PHACS and IMPAACT use the Frontier Science LDMS laboratory information management system to manage their sample collections.
The IMPAACT Network collaborates with the NICHD Domestic & International Pediatric & Maternal HIV & Other High-Priority Infectious Diseases Clinical Studies Network, the Adolescent Medicine Trials Network for HIV/AIDS Interventions, and with other NICHD-, NIH-, and organization-led HIV/AIDS research networks and projects.
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REPOSITORY SERVICES FOR THE MATERNAL AND PEDIATRIC INFECTIOUS DISEASE BRANCH (MPIDB)SPECIMENS
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项目类别:
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负责人:OGUZ MANDACI
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