The Johns Hopkins University - Uganda Clinical Trials Unit

约翰霍普金斯大学-乌干达临床试验单位（JHU-CTU）更新申请旨在继续 支持尖端的艾滋病毒相关研究，以扩大科学知识;并确定创新的艾滋病毒 预防和治疗干预措施，这将有助于结束全球艾滋病毒大流行。JHU-CTU已经 作为NIH支持的CTU成功参与，进行HIV预防和治疗临床试验， 在过去25年里，乌干达的两个临床研究中心重点关注预防母婴传播和高危妇女。 这一申请是在JHU-CTU预防母婴传播网络研究非常成功的基础上提出的。 艾滋病毒的传播（PMTCT）、儿科艾滋病毒治疗和高危艾滋病毒阴性人群中的艾滋病毒预防 妇女我们建议增加两个新的网络附属机构（艾滋病毒疫苗和成人治疗），并增加三个 在坎帕拉和拉凯建立新的社区康复服务系统，以接触各种成年艾滋病毒感染者和高危成年人 地区。这些以成人为重点的社区服务中心覆盖了乌干达艾滋病毒流行率最高的一些地区， 城市，城郊和农村环境，并将大大提高JHU乌干达CTU的能力，招募多样化的 HIV感染者和高危人群进行HIV治疗和预防试验。 JHU-CTU计划与DAIDS资助的四个HIV临床试验网络建立联系， 解决成人艾滋病毒治疗和相关的合并感染;孕产妇青少年和儿童治疗; 艾滋病毒预防;艾滋病毒疫苗;并大力支持各自的艾滋病毒领导 研究报告。拟议的社区服务中心可以接触到不同的艾滋病毒感染者群体， 风险群体。这些人群，包括新诊断的艾滋病毒感染的成年人，以及长期 治疗、妊娠和哺乳期艾滋病毒感染母亲及其暴露于艾滋病毒的婴儿;艾滋病毒感染者 青少年（主要是围产期艾滋病毒感染的长期幸存者）;基于 危险性行为（如性工作者、男男性行为者）;其他危险群体，包括渔民。每个乌干达CRS都有 进行艾滋病毒研究的杰出记录。JHU-乌干达CTU申请的研究目标包括： ·评估新的抗逆转录病毒和免疫干预措施的安全性和药代动力学， 提供治疗和预防的模式 ·参与使用新药/递送系统的高危人群中的多方面PrEP试验 ·评估新的HIV、TB、HBV疫苗以及其他疾病疫苗的安全性和免疫原性 艾滋病毒暴露人群和艾滋病毒感染人群中的合并感染 ·为临床试验中的新兴研究者和临床研究人员提供指导和培训 JHU-CTU/CRS研究人员将继续为尖端研究做出强有力的科学贡献 通过积极促进网络领导层的研究议程， 科学委员会和帮助领导研究方案和其他网络相关研究。

The Johns Hopkins University-Uganda Clinical Trial Unit (JHU-CTU) renewal application aims to continue to support cutting edge HIV related research to expand scientific knowledge; and to identify innovative HIV prevention and treatment interventions that will help end the global HIV pandemic. The JHU-CTU has successfully participated as an NIH supported CTU, conducting HIV prevention and treatment clinical trials with two clinical research sites (CRSs) focused on PMTCT and high-risk women in Uganda over the past 25 years. This application builds on the highly successful JHU-CTU Network research on Prevention of Mother to Child Transmission (PMTCT) of HIV, Pediatric HIV treatment, and HIV Prevention among high risk HIV negative women. We propose to add two new Network affiliation (HIV Vaccines and Adult Therapeutics) and add three new CRSs to access diverse adult HIV-infected and most-at-risk adult populations in Kampala and Rakai Districts. These adult-focused CRSs cover some of the highest-HIV prevalence areas in Uganda with distinct urban, peri-urban, and rural settings, and will greatly enhance the JHU-Uganda CTU’s capacity to recruit diverse HIV-infected and at-risk populations for HIV treatment and prevention trials. The JHU-CTU plans to associate with the four DAIDS funded HIV Clinical Trial networks, which are addressing Adult HIV Therapeutics and Related Co-infections; Maternal Adolescent and Pediatric Therapeutics; HIV Prevention; and HIV Vaccines; and to contribute strongly to support their respective HIV Leadership Research Agendas. The proposed CRSs have access to distinct and diverse populations of HIV infected or at risk groups. These populations, including newly diagnosed HIV infected adults, as well as those on long term treatment, pregnant and breastfeeding HIV infected mothers and their HIV exposed infants; HIV infected adolescents (primarily long-term survivors from perinatal HIV infection); at risk adolescents/adults based on risky sex (e.g. sex workers, MSM); other at risk groups including fisher folk. Each of the Uganda CRSs have outstanding records of conducting HIV research. Research Aims of the JHU-Uganda CTU application include: • Assessing the safety and pharmacokinetics of new antiretroviral and immune interventions and novel models of delivery for both treatment and prevention • Participating in multifaceted PrEP trials among high risk populations using new drugs/ delivery systems • Evaluating the safety and immunogenicity of new HIV, TB, HBV vaccines, as well as vaccines for other co-infections seen among both HIV exposed and HIV infected populated populations • Providing mentoring and training for rising investigators and clinical research staff in clinical trials The JHU-CTU/CRS investigators will continue their strong scientific contributions to the cutting-edge research agendas of the HIV leadership groups by actively contributing to the research agendas of the Network Leadership Scientific Committees and helping lead study protocols and other network related studies.