Johns Hopkins University-Guangxi, China Clinical Trials Unit

描述（由申请人提供）： 来自约翰霍普金斯大学（JHU）-中国广西疾病预防控制中心（CDC）合作的主要HIV研究者提议成立一个临床试验单位（JHU-中国广西疾病预防控制中心CTU），目的是在中国广西自治区曼宁市和横县两个发展良好的临床研究中心开展临床试验。该地区与越南接壤，是中国艾滋病毒感染者人数第三多的地区。JHU-广西中国CDC CTU建议在3个优先领域开展临床试验：1.其他HIV预防试验，特别是作为附属HPTN CTU在横县临床研究中心在静脉注射吸毒者（IDUs）中进行的试验;南宁临床研究中心HIV疫苗; 3.优化南宁临床研究中心的临床管理，包括合并症（HIV感染的成人和儿童）。 横县临床研究点的艾滋病毒血清阳性率为25%， HPTN 033在500名注射吸毒者中的血清发病率为3.1%，并计划开始在该注射吸毒者人群中进行III期随机suboxone干预试验，以预防HIV感染。曼宁临床研究中心目前正在使用中国开发的HIV疫苗进行第一个HIV疫苗I期试验，并拥有广西省最大的HIV ARV治疗诊所。已经建立了完善的基础设施，包括CAB、IRB、FWA、配备SCHARP数据传真系统的数据管理中心、先进的实验室能力（包括CD 4、病毒载量、HIV测序）、药房和接受GCP培训的研究人员，以支持这些研究中心。 JHU-广西CDC CTU的主要研究者（PI）将由JHU的布鲁克斯杰克逊（医学博士、工商管理硕士）担任，共同PI将由广西艾滋病预防控制中心的刘伟（医学博士）担任 （GXAIDS），总部设在中国广西疾控中心曼宁。JHU将作为主要申请机构，与广西疾控中心共同承担在临床研究中心开展临床试验的费用。 行政部门：

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: