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）：金山大学 Wits HIV 研究小组 (WHRG) CTU 是一个成熟的多学科研究小组，活跃于 HIV 和 TB 预防和治疗研究。该小组拥有 12 年 NIAID 资助的网络研究记录，发表了 300 多篇出版物。该应用程序由两名经验丰富的研究人员领导，他们是 lan Sanne 博士（医学博士）和 Helen Rees 博士（医学博士），他们在艾滋病毒治疗和预防方面拥有互补的技能。 WHRG CTU 的领导层为 NIAID 资助网络的研究议程做出了重大科学贡献，并对南非和国际上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 建立在现有的有效管理、质量保证和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： Wits Helen Joseph 医院 CRS（ Wits HJH CRS），提议与成人艾滋病毒和艾滋病毒相关感染治疗网络以及综合预防策略网络合作； Wits 生殖健康和艾滋病毒研究所 CRS (WRHI CRS) 建议与预防艾滋病毒感染微生物杀剂网络、预防艾滋病毒感染综合策略网络以及儿童和儿童艾滋病毒/艾滋病和艾滋病毒相关感染网络合作。孕产妇人群。 Sizwe 医院 CRS 是一家治疗耐多药结核病的住院机构，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。 CLS 和 BARC 提供实验室支持，这两个实验室都是 NIAID 资助网络中的活跃实验室。该应用程序描述了赠款管理、药房、数据管理、现场管理、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 网络中性能最高的站点。 WRHI 在 NIAID 网络中拥有良好的记录，并在成人和儿童中进行了大量艾滋病毒预防和治疗研究。拟议的 Sizwe CRS 已完成 FDA 耐多药结核病新药的 IND 研究。 WHRG 可以大量接触到各种艾滋病毒感染者和未感染者以及成人人群，使其非常适合应对新网络现有和新兴的优先事项。该应用程序得到了金山大学和卫生部的大力机构支持。