Clinical Trials Units for NIAID Networks (UM1)

描述（由申请人提供）：威特沃特斯兰德大学威特沃特斯兰德艾滋病研究小组（WHRG） CTU是一个完善的多学科研究小组，活跃于艾滋病和结核病预防和治疗研究。该小组在NIAID资助的网络研究方面有12年的记录，发表了300多篇论文。该应用程序由两位经验丰富的研究人员lan Sanne博士（医学博士）和Helen Rees博士（医学博士）领导，他们在艾滋病毒治疗和预防方面具有互补的技能。WHRG CTU的领导为niaid资助的网络的研究议程作出了重大的科学贡献，并为南非和国际上的艾滋病毒预防和治疗公共卫生政策和方案的实施作出了重大贡献。在这一继续申请中，WHRG提出了一个强大的CTU，它建立在有效的管理、质量保证和已经存在的研究基础设施之上，并扩大了约翰内斯堡三个临床研究地点（CRS）的研究范围：Wits Helen Joseph医院CRS (Wits HJH CRS)，建议与成人艾滋病毒和艾滋病毒相关感染治疗网络和综合预防战略网络合作；Wits生殖健康和艾滋病毒研究所CRS （WRHI CRS）提议与杀微生物剂预防艾滋病毒感染网络、预防艾滋病毒感染综合战略网络以及儿科和孕产妇人群中艾滋病毒/艾滋病和艾滋病毒相关感染网络合作。耐多药结核病住院机构Sizwe Hospital CRS提议与成人艾滋病毒/艾滋病和艾滋病毒相关感染治疗方法网络合作，研究耐多药结核病的治疗方法。实验室支持由CLS和BARC提供，这两个实验室都在niaid资助的网络中活跃。这个应用程序描述了拨款管理，药房，数据管理，网站管理，质量保证和科学专业知识。WHRG是DAIDS反恐组的杰出成员。Wits HJH CRS是ACTG网络中性能最高的站点。世界艾滋病研究所在NIAID网络中有着良好的记录，并在成人和儿童中进行了许多艾滋病毒预防和治疗研究。拟议的Sizwe CRS已经完成了FDA对耐多药结核病新药的IND研究。WHRG在很大程度上可以接触到各种感染和未感染艾滋病毒的儿童和成人，因此非常适合应对新网络现有和正在出现的优先事项。这一应用得到了Wits大学和卫生部的大力支持。

DESCRIPTION (provided by the applicant): The University of the Witwatersrand's Wits HIV Research Group (WHRG) CTU is a well-established, multidisciplinary group of researchers active in HIV and TB prevention and treatment research. The group has a12 year track-record of NIAID funded Network research resulting in over 300 publications. The application is led by two experienced investigators, Dr. lan Sanne (MD), and Dr. Helen Rees (MD), who have complementary skills in HIV treatment and prevention. The leadership of the WHRG CTU has made significant scientific contributions to the research agenda of the NIAID-funded networks, and major contributions to HIV prevention and treatment public health policy and program implementation in South Africa and internationally. In this continuation application, WHRG presents a strong CTU that builds on the effective management, quality assurance and research infrastructure already in place, and expands the scope of the research at three clinical research sites (CRS) in Johannesburg: Wits Helen Joseph Hospital CRS (Wits HJH CRS), proposes to work with the Network on Therapeutics for HIV and HIV-associated Infections in Adults and the Network for Integrated Prevention Strategies; Wits Reproductive Health and HIV Institute CRS (WRHI CRS), proposes to work with the Network on Microbicides to Prevent HIV Infection, the Network on Integrated Strategies to Prevent HIV Infection, and the Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations. Sizwe Hospital CRS, an in-patient facility for MDRTB proposed to work with the Network on Therapeutics for HIV/AIDS and HIV associated infections in Adults to study therapeutics for MDRTB. Laboratory support provided by CLS and BARC, both active laboratories in the NIAID-funded Networks. This application describes Grants Management, Pharmacy, Data Management, Site Management, Quality Assurance and scientific expertise. The WHRG is an outstanding performer within the DAIDS CTU establishment. Wits HJH CRS is the highest performing site of the ACTG Network. WRHI has a strong track record in the NIAID Networks and has conducted numerous HIV prevention and treatment studies in adults and children. The proposed Sizwe CRS has completed FDA IND studies in novel drugs for MDR-TB. The WHRG has significant access to diverse HIV infected and uninfected pediatric and adult populations, making it ideally suited to respond to the existing and emerging priorities of the new networks. This application has significant institutional support from both Wits University and the Department of Health.