Statistical and Data Management Center for the AIDS Clinical Trials Group

艾滋病临床试验组统计和数据管理中心

• 批准号: 8268981
• 负责人: Michael David Hughes
• 金额: $ 1506.15万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-29 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8268981
• 关键词: AIDS clinical trial group; AIDS prevention; Address; Adverse effects; Area; Clinical; Clinical Data; Clinical Management; Clinical Trials; Collaborations; Commit; Communication; Computers; Consequences of HIV; Data; Data Collection; Databases; Development; Electronics; Ensure; Epidemiology; Funding; HIV; HIV Infections; Head; Individual; Infection; International; Laboratories; Leadership; Life; Methods; Mission; Monitor; National Institute of Allergy and Infectious Disease; National Institute of Dental and Craniofacial Research; Office of Administrative Management; Pathogenesis; Play; Policies; Prevention; Principal Investigator; Procedures; Protocols documentation; Randomized; Research; Research Design; Research Personnel; Research Priority; Research Support; Resource Allocation; Resources; Shipping; Ships; Site; Specimen; Support System; System; Technology; Therapeutic Human Experimentation; Therapeutic Intervention; Training; Translational Research; United States; Vaccine Research; Vertical Disease Transmission; Work; base; data acquisition; data management; design; drug development; experience; flexibility; high standard; improved; innovation; member; operation; organizational structure; programs; research and development; research study; software systems; transmission process; vaccine development

DESCRIPTION (provided by applicant): This application is a proposal to serve as the Statistical and Data Management Center (SDMC) of the AIDS Clinical Trials Group (ACTG), in affiliation with the ACTG Leadership Group headed by Dr. Constance A. Benson (UCSD). The ACTG is proposing a therapeutic research agenda to address objectives in the NIAID high priority research areas of Translational Research/Drug Development; Optimization of Clinical Management; Vaccine Research and Development; Prevention of Mother-to-Child Transmission of HIV Infection; and Prevention of HIV. In addition, the ACTG is applying for funding to carry out research in the NIDCR priority area. Our Specific Aims are to support the research agenda of the ACTG by providing a group of highly experienced statisticians, data managers and other professionals who are knowledgeable in all aspects of HIV therapeutic research and an organizational structure that promotes this work with the ACTG; to provide expertise and high quality clinical and laboratory data management and communications systems to support the development, conduct and analysis of ACTG studies; and to advance the mission of the ACTG through innovation in study design and analysis, providing leadership in cross-study analyses and collaborating effectively with other HIV Trials Networks and HIV research organizations. The expertise provided by the SDMC will help advance HIV therapeutic research by ensuring that ACTG clinical trials and other studies are efficiently designed and analyzed to the highest standards. This research will continue to make significant contributions in advancing optimal treatment of HIV-infected individuals both in the Unites States and internationally. Translational Research/Drug Development

描述（由申请人提供）：本申请是一份作为艾滋病临床试验组（ACTG）统计和数据管理中心（SDMC）的提案，隶属于ACTG领导小组，由Dr. Constance a . Benson （UCSD）领导。ACTG正在提出一项治疗研究议程，以解决NIAID转化研究/药物开发高优先研究领域的目标；优化临床管理；疫苗研究与开发；预防艾滋病毒母婴传播；预防艾滋病毒。此外，ACTG正在申请资助，以开展NIDCR优先领域的研究。我们的具体目标是通过提供一组经验丰富的统计学家、数据管理人员和其他专业人员来支持ACTG的研究议程，他们对艾滋病毒治疗研究的各个方面都很了解，并建立一个组织结构来促进ACTG的这项工作；提供专业知识和高质量的临床和实验室数据管理和通信系统，以支持ACTG研究的发展、进行和分析；通过创新研究设计和分析，在交叉研究分析方面发挥领导作用，并与其他艾滋病毒试验网络和艾滋病毒研究组织进行有效合作，推进ACTG的使命。SDMC提供的专业知识将有助于推进艾滋病毒治疗研究，确保ACTG临床试验和其他研究按照最高标准进行有效设计和分析。这项研究将继续在推进美国和国际上艾滋病毒感染者的最佳治疗方面作出重大贡献。

项目成果

Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.

• DOI: 10.1097/qad.0b013e32835221eb
• 发表时间: 2012-06-01
• 期刊: AIDS (London, England)
• 作者: Lorenzana SB;Hughes MD;Grinsztejn B;Collier AC;Luz PM;Freedberg KA;Wood R;Levison JH;Mugyenyi PN;Salata R;Wallis CL;Weinstein MC;Schooley RT;Walensky RP
• 通讯作者: Walensky RP

Improving noninvasive methods of assessing liver fibrosis in patients with hepatitis C virus/human immunodeficiency virus co-infection.

• DOI: 10.1016/j.cgh.2008.12.016
• 发表时间: 2009-04
• 期刊: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
• 作者: Shire NJ;Rao MB;Succop P;Buncher CR;Andersen JA;Butt AA;Chung RT;Sherman KE;AIDS Clinical Trials Group 5178 Study Group
• 通讯作者: AIDS Clinical Trials Group 5178 Study Group

Cardiac risk: not so simple.

心脏风险：没那么简单。

• DOI: 10.1086/649898
• 发表时间: 2010
• 期刊: The Journal of infectious diseases
• 作者: Aberg,JudithA;Ribaudo,Heather
• 通讯作者: Ribaudo,Heather

Genome-Wide Association Study of Human Immunodeficiency Virus (HIV)-1 Coreceptor Usage in Treatment-Naive Patients from An AIDS Clinical Trials Group Study.

• DOI: 10.1093/ofid/ofu018
• 发表时间: 2014-03
• 期刊: Open forum infectious diseases
• 影响因子: 4.2
• 作者: Henrich TJ;McLaren PJ;Rao SS;Lin NH;Hanhauser E;Giguel F;Gulick RM;Ribaudo H;de Bakker PI;Kuritzkes DR
• 通讯作者: Kuritzkes DR

Extended therapy with pegylated interferon and weight-based ribavirin for HCV-HIV coinfected patients.

对 HCV-HIV 共感染患者使用聚乙二醇化干扰素和基于体重的利巴韦林进行延长治疗。

• DOI: 10.1310/hct1302-70
• 发表时间: 2012
• 期刊: HIV clinical trials
• 作者: Chung,RaymondT;Umbleja,Triin;Chen,JenniferY;Andersen,JanetW;Butt,AdeelA;Sherman,KennethE;ActgA5178StudyTeam
• 通讯作者: ActgA5178StudyTeam