Johns Hopkins University Kampala-Nanning Clinical Trial Unit

描述(由申请人提供)：我们建议建立一个约翰霍普金斯大学临床试验中心(CTU)，下设三个附属的临床研究中心：两个在乌干达的坎帕拉，一个在中国的曼宁。拟议的CTU结构包括加入两个CTU领导和临床研究网站，这些网站在过去的赠款周期中表现出色。成功的表现包括超过3700名参与者的高注册和83%至97%的保留率；作为网络科学贡献的领导者的一贯记录；以及在目前NIH艾滋病毒临床试验网络的三个范围内成功地进行高优先级艾滋病毒预防和治疗临床试验。约翰霍普金斯大学坎帕拉-南宁(K-N)CTU的提案将由两位PD/PI领导，玛丽·格伦·福勒教授和布鲁克斯·杰克逊教授，他们在过去22年中担任不同的角色，共同开展艾滋病毒预防和艾滋病毒治疗及其并发症的临床试验。这个CTU将在马里兰州巴尔的摩的JHU设立中央行政基地，并将在乌干达坎帕拉的两个CRS和中国南宁的一个CRS进行网络艾滋病毒临床方案。 1.Makerere U-Johns Hopkins U研究合作(MU-JHU)CRS将隶属于 A)儿童和青少年艾滋病毒/艾滋病和艾滋病毒相关感染的临床研究网络 将重点放在防止母婴传播和治疗感染艾滋病毒的婴幼儿方面；b)预防艾滋病毒感染综合战略网络；c)预防艾滋病毒感染杀菌剂网络。 2.儿童传染病诊所/贝勒医学院儿童基金会 乌干达研究所(PIDC)CRS是乌干达的一个独立的非营利非政府组织实体，将专注于儿童和青少年艾滋病毒治疗试验，并将隶属于感染网络 在儿科和产妇群体中。 3.南宁市疾病控制与预防中心在南宁的站点中国将隶属于a)艾滋病毒/艾滋病网络和 儿童和孕产妇中的艾滋病毒相关感染，重点是预防母婴传播和治疗感染艾滋病毒的婴幼儿；b)预防艾滋病毒感染综合战略网络；c)艾滋病毒及相关感染治疗网络。

DESCRIPTION (provided by applicant): We propose to establish a Johns Hopkins (JHU) Clinical Trial Unit (CTU) with three affiliated Clinical Research sites (CRS): two in Kampala, Uganda, and one in Manning, China. The proposed CTU structure includes joining of two CTU leaderships and clinical research sites with outstanding performance over the past grant cycle. The successful performance includes high enrollment of over 3700 participants and retention rates between 83% and 97%; a consistent track record as the leader of network scientific contributions; and successful conduct of high priority HIV Prevention and Therapeutic clinical trials within three of the current NIH HIV Clinical Trial Networks. The Johns Hopkins Kampala -Nanning (K-N) CTU proposal will be led by two PD/PIs, Professors Mary Glenn Fowler and Brooks Jackson, who have worked collaboratively in various roles over the past 22 years to conduct clinical trials on HIV prevention and HIV therapeutics and its complications. This CTU will have its central administrative base at JHU in Baltimore, MD and will conduct the network HIV clinical protocols at two CRSs in Kampala, Uganda and one CRS in Nanning, China. 1. The Makerere U. Johns Hopkins U. Research Collaboration (MU-JHU) CRS will be affiliated with a) the Clinical Research Network for HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations focusing on PMTCT and treatment of HIV infected infants and young children; b) the Network on Integrated Strategies to Prevent HIV Infection; and c) the Network on Microbicides to Prevent HIV Infection. 2. The Pediatric Infectious Diseases Clinic/ Baylor College of Medicine Children's Foundation of Uganda Institute (PIDC) CRS, an independent nonprofit NGO entity in Uganda will focus on pediatric and adolescent HIV treatment trials and will be affiliated with the Network on Infections in Pediatric and Maternal Populations. 3. The Nanning CRS site in Nanning China will be affiliated with a) the Network for HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations focusing on PMTCT and treatment of HIV infected infants and young children; b) the Network on Integrated Strategies to Prevent HIV Infection; and c) the Network on Therapeutics for HIV and associated infections.