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: 7762789
• 负责人: Jay B Jackson
• 金额: $ 138.67万
• 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 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7762789
• 关键词: AIDS prevention; 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; Data; HIV; HIV Infections; HIV Seroprevalence; HIV prevention trial; HIV vaccine; Intervention Trial; Laboratories; Persons; Pharmacy facility; Phase; Population; Principal Investigator; Province; Randomized; Research Ethics Committees; Research Infrastructure; Research Personnel; Schedule; Site; System; Training; Universities; Vietnam; Viral Load result; base; clinical research site; cost; data management; 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）：来自约翰霍普金斯大学(JHU) -广西中国疾病预防控制中心（CDC）合作的主要HIV研究人员提出了一个临床试验单元（JHU-广西中国疾病预防控制中心CTU），目的是在中国广西自治区曼宁市和横县两个发达的临床研究地点进行临床试验。该地区与越南接壤，是中国感染艾滋病毒人数第三多的地区。jhu -广西中国疾病预防控制中心CTU建议在3个重点领域开展临床试验：其他艾滋病毒预防试验，特别是在静脉吸毒者（IDUs）中作为附属HPTN CTU在衡县临床研究站点；2. 南宁临床试验点HIV疫苗试验研究3. 优化南宁临床研究点的临床管理，包括合并症（HIV感染成人和儿童）。