Johns Hopkins University-Guangxi, China Clinical Trials Unit

约翰霍普金斯大学中国广西临床试验中心

• 批准号: 8787311
• 负责人: Jay B Jackson
• 金额: $ 31.75万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2015-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8787311
• 关键词: AIDS/HIV problem; Adult; Area; Centers for Disease Control and Prevention (U.S.); Child; China; Chinese People; Cities; Clinic; Clinical Management; Clinical Trials Unit; Collaborations; Comorbidity; Conduct Clinical Trials; County; HIV; HIV Infections; HIV Seroprevalence; HIV prevention trial; HIV vaccine; Institutional Review Boards; Intervention Trial; Laboratories; Persons; Pharmacy facility; Phase; Population; Prevention; Principal Investigator; Province; Randomized; Research Infrastructure; Research Personnel; Schedule; Site; System; Training; Universities; Vietnam; Viral Load result; base; clinical research site; cost; data management; disorder prevention; intravenous drug user; prevent

DESCRIPTION (provided by applicant): Leading HIV investigators from the Johns Hopkins University (JHU) - Guangxi China Center for Disease Control and Prevention (CDC) Collaboration propose a Clinical Trials Unit (JHU-Guangxi China CDC CTU) for the purpose of conducting clinical trials at two well developed clinical research sites in Manning City and Heng County in the Guangxi autonomous region of China. This region, which borders Vietnam, has the third largest number of HIV infected persons in China. The JHU-Guangxi China CDC CTU proposes to conduct clinical trials in 3 priority areas: 1. Other HIV prevention trials particularly among intravenous drug users (IDUs) as an affiliated HPTN CTU at the Heng County clinical research site; 2. HIV Vaccines at the Nanning clinical research site; 3. Optimization of clinical management including co-morbidities (HIV infected adults and children) at the Nanning clinical research site. The Heng County clinical research site was shown to have an HIV seroprevalence rate of 25% and seroincidence rate of 3.1% in HPTN 033 among 500 IDUs and is scheduled to begin a Phase III randomized suboxone intervention trial among this IDU population to prevent HIV infection. The Manning clinical research site is currently conducting the first Phase I HIV Vaccine trial using a Chinese developed HIV vaccine and has the largest HIV ARV treatment clinic in Guangxi province. A well developed infrastructure is already in place including a CAB, IRB, an FWA, a data management center with the SCHARP DATA FAX system, sophisticated laboratory capabilities (including CD4, viral load, HIV sequencing), pharmacy, and study staff with GCP training to support these sites. The principal Investigator (PI) of the JHU-Guangxi CDC CTU will be Brooks Jackson, MD, MBA based at JHU, and the Co-PI will be Liu Wei, MD of the Guangxi Center for HIV/AIDS Prevention and Control (GXAIDS), based at the Guangxi CDC Manning, China. JHU will be the primary applicant organization which will subcontract with the Guangxi CDC those costs to conduct clinical trials at the clinical research sites. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：约翰·霍普金斯大学（JHU）的主要艾滋病毒研究人员 - 中国中国疾病控制与预防中心（CDC）合作提出了一个临床试验单位（JHU -GUANGXI CHAM CIDC CTU），目的是在两个良好发达的临床研究现场在Manning City and Hengy County in the Manning County in the Manning County inthemist of Henenning County in the Manning County in the Manning County in the Manning County in the Manning County in the Manning County in the Manning County in the Guangans in guanganci的临床试验。与越南接壤的该地区是中国受艾滋病毒感染者的第三大。 Jhu-guangxi中国CDC CTU提议在3个优先领域进行临床试验：1。其他预防HIV预防试验，尤其是在静脉注射吸毒者中（IDUS）作为亨格县临床研究地点的附属HPTN CTU； 2. Nanning临床研究地点的HIV疫苗； 3。在Nanning临床研究地点的临床管理优化，包括合并症（受HIV感染的成人和儿童）。 亨格县临床研究网站的HIV血清阳性率为25％， 在500 IDU中，HPTN 033的血清浓度率为3.1％，并计划在该IDU人群中开始进行III期随机亚智酮干预试验，以防止HIV感染。 Manning临床研究地点目前正在使用中国发达的HIV疫苗进行第一阶段I HIV疫苗试验，并在广西省拥有最大的HIV ARV治疗诊所。已经建立了一个良好发达的基础设施，包括CAB，IRB，FWA，具有SCHARP数据传真系统的数据管理中心，复杂的实验室功能（包括CD4，病毒载量，HIV测序），药房和GCP培训的研究人员，以支持这些站点。 Jhu-Guangxi CDC CTU的首席研究员（PI）将是位于JHU的MBA的Brooks Jackson，Co-Pi将是Guangxi HIV/AIDS预防和控制中心的MD Liu Wei （GXAIDS），总部位于中国广西疾病预防控制中心。 JHU将是主要的申请组织，将与广西疾病预防局分包合同这些费用在临床研究地点进行临床试验。 管理组件：