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）：来自约翰·霍普金斯大学 (JHU) - 广西中国疾病预防控制中心 (CDC) 合作的主要艾滋病毒研究人员提议成立一个临床试验单位（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的两个成熟的临床研究中心进行临床试验。该地区与越南接壤，是中国艾滋病毒感染人数第三多的地区。 JHU-广西中国疾病预防控制中心 CTU 提议在 3 个优先领域开展临床试验： 1. 作为附属 HPTN CTU 在横县临床研究点进行其他艾滋病毒预防试验，特别是静脉吸毒者 (IDU) 的试验； 2、南宁临床研究点HIV疫苗； 3.优化南宁临床研究点的临床管理，包括合并症（HIV感染的成人和儿童）。 横县临床研究点HIV血清阳性率为25% 在 500 名注射吸毒者中，HPTN 033 的血清发生率为 3.1%，并计划在该注射吸毒者人群中开始一项 III 期随机 suboxone 干预试验，以预防 HIV 感染。曼宁临床研究基地目前正在开展首个使用中国自主研发的艾滋病毒疫苗的一期艾滋病毒疫苗试验，并拥有广西省最大的艾滋病毒抗逆转录病毒治疗诊所。完善的基础设施已经到位，包括 CAB、IRB、FWA、带有 SCHARP DATA FAX 系统的数据管理中心、先进的实验室能力（包括 CD4、病毒载量、HIV 测序）、药房和经过 GCP 培训的研究人员来支持这些站点。 JHU-广西疾病预防控制中心 CTU 的首席研究员 (PI) 为 JHU 医学博士、MBA 布鲁克斯·杰克逊 (Brooks Jackson)，联合 PI 为广西艾滋病防治中心医学博士刘伟 （GXAIDS），总部设在中国广西曼宁疾病预防控制中心。 JHU将作为主要申请机构，将与广西疾病预防控制中心分包在临床研究地点进行临床试验的费用。 行政部分：