The Johns Hopkins University - Uganda Clinical Trials Unit

约翰霍普金斯大学-乌干达临床试验单元(JHU-CTU)续签申请旨在继续 支持与艾滋病毒相关的前沿研究，以扩大科学知识；并确定创新的艾滋病毒 有助于结束全球艾滋病毒大流行的预防和治疗干预措施。JHU-CTU 作为NIH支持的CTU，成功参与了HIV预防和治疗的临床试验 两个临床研究网站(CRSS)在过去25年里重点关注乌干达的母婴传播和高危妇女。 该应用程序建立在非常成功的JHU-CTU预防母婴传播网络研究的基础上 高危HIV阴性人群HIV传播(母婴传播)、儿童HIV治疗和HIV预防 女人。我们建议增加两个新的网络联盟(艾滋病毒疫苗和成人治疗)，并增加三个 新的CRSS将在坎帕拉和拉凯接触到不同的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CRS覆盖了乌干达一些艾滋病毒流行率最高的地区， 城市、城市周边和农村环境，并将极大地加强联合胡塞-乌干达反恐联盟招募不同 艾滋病毒感染者和高危人群用于艾滋病毒治疗和预防试验。 JHU-CTU计划与DAIDS资助的四个艾滋病毒临床试验网络合作，这四个网络是 解决成人艾滋病毒治疗和相关的混合感染问题；母亲、青少年和儿童治疗； 艾滋病毒预防；艾滋病毒疫苗；并大力支持其各自的艾滋病毒领导层 研究议程。拟议的社区卫生服务可以接触到不同和不同的艾滋病毒感染人群或 风险群体。这些人群，包括新诊断的感染艾滋病毒的成年人以及长期感染艾滋病毒的人 治疗，怀孕和哺乳感染艾滋病毒的母亲及其接触艾滋病毒的婴儿；感染艾滋病毒 青少年(主要是围产期艾滋病毒感染的长期幸存者)；高危青少年/成年人 高危性行为(例如性工作者、男男性接触者)；包括渔民在内的其他高危人群。每个乌干达CRSS都有 从事艾滋病毒研究的杰出记录。JHU-乌干达CTU应用的研究目标包括： ·评估新的抗逆转录病毒和免疫干预措施和新型药物的安全性和药代动力学 治疗与预防并举的服务模式 ·在使用新药/给药系统的高危人群中参与多方面的PrEP试验 ·评价新的艾滋病毒、结核病、乙肝疫苗以及其他疫苗的安全性和免疫原性 在HIV暴露人群和HIV感染人群中发现的联合感染 ·为临床试验中的新兴研究人员和临床研究人员提供指导和培训 JHU-CTU/CRS调查人员将继续为尖端研究做出强大的科学贡献 艾滋病毒领导小组的议程，积极促进网络领导的研究议程 科学委员会并帮助领导研究方案和其他与网络有关的研究。

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.