PEDIATRIC AIDS CLINICAL TRIALS UNIT

儿科艾滋病临床试验单位

• 批准号: 6415833
• 负责人: ROSS E MCKINNEY
• 金额: $ 89.12万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-06-01 至 2002-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6415833
• 关键词: 2'3' dideoxycytidine; 2'3' dideoxyinosine; AIDS /HIV test; AIDS education /prevention; AIDS therapy; AIDS vaccines; HIV infections; Mycobacterium avium; Pneumocystis carinii; Pneumocystis pneumonia; Streptococcus pneumoniae vaccine; adolescence (12-20); antiviral agents; antiviral antibody; atovaquone; behavioral /social science research tag; chemoprevention; clinical research; clinical trial phase I; combination chemotherapy; community; cooperative study; cytomegalovirus; dapsone; data management; drug administration routes; epidemiology; family; ganciclovir; health behavior; human immunodeficiency virus 1; human pregnant subject; human subject; human therapy evaluation; immunotherapy; measles vaccine; microorganism disease chemotherapy; monoclonal antibody; neuropsychological tests; nevirapine; opportunistic infections; outcomes research; passive immunization; pathologic process; pediatric AIDS; pharmacokinetics; phenotype; polymerase chain reaction; premature infant human; protease inhibitor; retinitis; stavudine; tissue /cell culture; vertical transmission; virus DNA; virus RNA; virus infection mechanism; zidovudine

The Duke Pediatric AIDS Clinical Trials Unit is a multicenter program which provides ACTG protocol care to HIV infected and exposed children throughout North Carolina, southern Virginia, and northern South Carolina. To provide these services in a cost-effective, regional approach, the North Carolina Children's AIDS Network (NC-CAN) was created. The core of the network is at Duke, where the largest number of patients are seen, data entry and quality assurance activities are based, and interface occurs with several large basic science programs. There is a full sub-unit at the University of North Carolina at Chapel Hill, which began with a focus on adolescents (because of a large hemophilia center), but has evolved to emphasize perinatal prophylaxis and primary therapy trials. The NC-CAN has two Outreach Clinics, at the Carolinas Medical Center in Charlotte, NC, and the Brenner Children's Hospital at Bowman Gray School of Medicine in Winston-Salem, NC. To serve these clinics, a physician-nurse team from Duke travels to Charlotte and Winston-Salem on a regularly scheduled basis (every 2 to 4 weeks for each site). In the Outreach Clinics, patients are seen by their local pediatric infectious diseases specialist for care, and by the Duke Travel Team for ACTG protocol related issues. Thus, patients can participate in ACTG protocols closer to their local community, making access to cutting edge medical care more easily available for this generally poor and disadvantaged population. The Travel Team also participates in Screening Clinics in Greenville, NC (East Carolina University School of Medicine) and Roanoke, VA (Community Hospital of the Roanoke Valley) where patients are seen and evaluated regarding their suitability for ACTG protocols, again in coordination with their local pediatric infectious diseases specialists. In addition to providing medical care closer to the patients' homes, the NC-CAN model as a whole allows the Duke PACTU to maintain tight quality assurance, since the forms are completed by Duke staff, and to provide Optimum laboratory specimen delivery, since clinical specimens from the Outreach and Screening Clinics are hand delivered to ACTG certified retrovirology and cytometry labs at UNC and Duke (respectively).

杜克儿科艾滋病临床试验单位是一个多中心项目 为艾滋病毒感染和暴露的儿童提供ACTG协议护理 整个北卡罗来纳州，弗吉尼亚州南部，和北方南部 卡罗莱纳。为了以具有成本效益的区域性方式提供这些服务， 北卡罗来纳州儿童艾滋病网络（NC-CAN） 创造网络的核心是在杜克，那里的人数最多 的患者，数据输入和质量保证活动， 的基础上，和接口发生与几个大型基础科学计划。 在北卡罗来纳州的查珀尔大学有一个完整的子单元 希尔，这开始与青少年的重点（因为大 血友病中心），但已发展到强调围产期预防 和初级治疗试验。NC-CAN有两个外展诊所， 位于北卡罗来纳州夏洛特的科维纳斯医疗中心和布伦纳儿童医院 位于北卡罗来纳州温斯顿-塞勒姆的鲍曼格雷医学院医院。到 为这些诊所服务，来自杜克的一个医生护士小组前往 夏洛特和温斯顿-塞勒姆定期（每2至 每个站点4周）。 在外展诊所， 他们当地的儿科传染病专家进行护理， 杜克旅行团队的ACTG协议相关问题。因此，患者 可以参与更接近当地社区的ACTG协议， 使人们更容易获得尖端的医疗服务， 这是一个普遍贫穷和弱势的群体。旅游团队也 参加北卡罗来纳州格林维尔（东卡罗莱纳）的筛查诊所 大学医学院）和弗吉尼亚州罗阿诺克（ 罗阿诺克山谷），在那里， 他们对ACTG协议的适用性，再次与他们的 当地儿科传染病专家。 除了 提供更接近患者家庭的医疗护理，NC-CAN模式 作为一个整体允许杜克PACTU保持严格的质量保证， 由于表格是由杜克员工填写的， 实验室样本交付，因为临床样本来自 外展和筛查诊所由ACTG认证的 逆转录病毒学和细胞计量学实验室（分别位于马里兰大学和杜克大学）。