Clinical Trials Units for NIAID Networks (UM1)

NIAID 网络临床试验单位 (UM1)

• 批准号: 8608248
• 负责人: Helen Rees
• 金额: $ 295.25万
• 依托单位: WITS HEALTH CONSORTIUM (PTY), LTD
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-15 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8608248
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS related cancer; AIDS/HIV problem; Address; Adherence; Adolescent; Adult; Adverse effects; Africa; Anti-Retroviral Agents; Antitubercular Agents; Breast Feeding; Child; Childhood; Clinical Research; Clinical Trials; Clinical Trials Unit; Communities; Comorbidity; Country; Development; Diagnosis; Diagnostic; Diagnostic tests; Dose; Drug Combinations; Drug Formulations; Drug Interactions; Effectiveness; Epidemic; Extreme drug resistant tuberculosis; Funding; Grant; HIV; HIV Infections; HIV Seropositivity; Health; Health Policy; Herpesviridae; High Risk Woman; Hospitals; Human Papillomavirus; Infection; Institutes; Intervention; Kaposi Sarcoma; Laboratories; Lead; Leadership; Life; Malignant Neoplasms; Mission; Morbidity - disease rate; Multidrug-Resistant Tuberculosis; Mycobacterium tuberculosis; National Institute of Allergy and Infectious Disease; Oral; Pathogenesis; Patients; Pharmaceutical Preparations; Pharmacy facility; Phase; Population; Prevalence; Prevention; Prevention strategy; Preventive Intervention; Public Health; Publications; Regimen; Reproductive Health; Research; Research Infrastructure; Research Personnel; Safety; Secondary Prevention; Sexual Health; Site; South Africa; Testing; Therapeutic; Therapeutic Studies; Treatment Protocols; Tuberculosis; Tuberculosis Vaccines; Universities; Validation; Vertical Disease Transmission; Viral; Viral hepatitis; Wit; Work; base; burden of illness; clinical research site; data management; design; experience; immunogenicity; improved; innovation; men who have sex with men; microbicide; mortality; multidisciplinary; novel; novel diagnostics; prevent; prevention service; programs; quality assurance; skills; treatment strategy; tuberculosis drugs; tuberculosis treatment; young woman

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.

描述（由申请人提供）：威特沃特斯兰德大学的Wits HIV研究小组（WHRG）CTU是一个完善的多学科研究小组，活跃于HIV和TB预防和治疗研究。该小组有一个12年的跟踪记录NIAID资助的网络研究，导致超过300出版物。该申请由两名经验丰富的研究人员领导，伊恩桑内博士（医学博士）和海伦里斯博士（医学博士），他们在艾滋病毒治疗和预防方面具有互补的技能。WHRG CTU的领导层为NIAID资助的网络的研究议程做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计划的实施做出了重大贡献。在此延续申请中，WHRG展示了一个强大的CTU，该CTU建立在有效的管理、质量保证和已经到位的研究基础设施的基础上，并扩大了约翰内斯堡三个临床研究中心（CRS）的研究范围：海伦约瑟夫医院（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）提议与预防艾滋病毒感染杀微生物剂网络、预防艾滋病毒感染综合战略网络以及儿童和孕产妇人群艾滋病毒/艾滋病和艾滋病毒相关感染网络合作。Sizwe医院CRS是一家耐多药结核病住院机构，提议与成人艾滋病毒/艾滋病和艾滋病毒相关感染治疗网络合作，研究耐多药结核病的治疗方法。实验室支助由CLS和BARC提供，这两个实验室都是国家艾滋病研究所资助的网络中的活跃实验室。本申请介绍了赠款管理、药房、数据管理、研究中心管理、质量保证和科学专业知识。WHRG是DAIDS CTU机构中的杰出表现者。Wits HJH CRS是ACTG网络中性能最高的网站。WRHI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已经完成了针对MDR-TB新药的FDA IND研究。妇女健康和生殖健康小组能够接触到各种艾滋病毒感染和未感染的儿童和成人群体，使其非常适合应对新网络现有和新出现的优先事项。该应用程序得到了Wits University和Department of Health的大力支持。