Johns Hopkins University-Guangxi, China Clinical Trials Unit

描述(申请人提供)：约翰霍普金斯大学和广西中国疾病预防控制中心合作的艾滋病毒研究带头人建议成立一个临床试验单位(约翰霍普金斯大学和广西中国疾控中心合作)，以便在广西中国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。这个与越南接壤的地区，是中国艾滋病病毒感染者数量第三多的地区。协和广西中国疾病预防控制中心建议在3个优先领域进行临床试验：1.作为横县临床研究中心附属HPTN CTU的其他HIV预防试验；2.南宁临床研究中心的HIV疫苗；3.优化南宁临床研究中心的临床管理，包括共病(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%， 在500名注射吸毒者中，HPTN 033的血清发病率为3.1%，并计划在该注射吸毒者人群中开始第三阶段随机亚酮干预试验，以预防艾滋病毒感染。曼宁临床研究网站目前正在进行使用中国开发的艾滋病毒疫苗的第一阶段艾滋病毒疫苗试验，并拥有广西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，包括驾驶室、IRB、FWA、具有SCHARP数据传真系统的数据管理中心、先进的实验室功能(包括CD4、病毒载量、艾滋病毒测序)、药房和经过GCP培训的研究人员，以支持这些网站。 JHU-广西疾控中心CTU的首席调查员(PI)将是JHU的MBA医学博士布鲁克斯·杰克逊(Brooks Jackson)，共同调查者将是广西艾滋病预防控制中心的刘薇博士 (GXAIDS)，驻广西疾控中心曼宁，中国。JHU将是主要的申请机构，将把在临床研究地点进行临床试验的费用分包给广西疾控中心。 管理组件：

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: