University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit

摘要 北卡罗来纳大学(UNC)全球艾滋病毒预防和治疗临床试验单位 (CTU)拥有良好的高质量、创新的临床研究和强大的网络 和科学领导力。CTU与感染和感染的关键人群接触 在美国东南部、南部非洲和东南亚，艾滋病毒感染风险很高。我们的反恐小组是由 三名经验丰富的首席调查员(Joseph Eron MD、Mina Hosseiniour MD和David Wohl MD)，并将支持所有四个NIH临床试验网络(CTN)；成人治疗 战略、艾滋病毒预防、疫苗预防和儿科、青少年和产妇 治疗策略。我们的四个经验丰富的临床研究站点(CRS)包括教堂山 由Greensboro CRS(成人)Wohl博士领导的CRS(成人策略、预防和疫苗) 战略、预防和疫苗CTN)，由马拉维CRS的Cornelius Van Dam MD(所有四人)领导 由Lameck Chinula MD和越南CRS(成人战略、预防和疫苗)领导的CTN (CTN：行情)，由薇薇安·戈博士领导。艾滋病毒携带者包括那些新诊断的人(包括 急性感染)，PWH在治疗中稳定受到抑制，PWH有粘附性挑战需要护理 或者药物治疗和那些携带抗药性艾滋病毒的人。高危人群包括有性行为的男性 男性(MSM)包括有色人种年轻男性、变性人女性(TGW)、 注射毒品(PWID)和非洲少女和妇女，包括怀孕妇女。 我们将登记有合并疾病风险的PWH和PWH，或者没有HIV和共同流行病原体的PWH 如结核病(TB)和乙肝病毒(乙肝)。我们拥有技术娴熟、经验丰富的临床和 翻译调查员与不同性别的初级调查员携手合作 以及种族，在美国和国际环境中，谁将参与并科学地执行网络 议程。具有全球代表性的资深科学家和公共卫生领导人在我们的 科学和战略咨询小组为反恐联盟领导班子提供建议。反恐联盟管理部门 有一个高度有组织的结构，对我们的研究团队和CRSS做出反应。每个CRS 以互动、开放的心态让代表受影响人群的社区参与进来 道路。最先进的通信和经验丰富、杰出且组织严密的实验室， 药房、监管、质量和数据管理为CTU、CRSS提供支持。使用这种健壮的 框架北卡罗来纳大学全球CTU处于最佳位置，以继续我们的科学和网络 领导力和临床试验支持所有四个NIH艾滋病毒网络的议程。

Abstract The University of North Carolina (UNC) Global HIV Prevention and Treatment Clinical Trials Unit (CTU) has a well-established record of high quality, innovative clinical research, strong network and scientific leadership. The CTU engages with critically important populations infected with and at high risk of HIV in southeastern US, southern Africa and southeast Asia. Our CTU is led by three experienced principal investigators (Joseph Eron MD, Mina Hosseinipour MD and David Wohl MD) and will support all four NIH Clinical Trials Networks (CTN); Adult Therapeutic Strategies, HIV Prevention, Vaccine Prevention and Pediatric, Adolescent and Maternal Therapeutic Strategies. Our four experienced Clinical Research Sites (CRS) include Chapel Hill CRS (Adult Strategies, Prevention and Vaccine CTN) led by Dr. Wohl, Greensboro CRS (Adult Strategies, Prevention and Vaccine CTN) led by Cornelius Van Dam MD, Malawi CRS (all four CTN) led by Lameck Chinula MD and Vietnam CRS (Adult Strategies, Prevention and Vaccine CTN) led by Vivian Go PhD. Participants with HIV include those newly diagnosed (including with acute infection), PWH stably suppressed on therapy and PWH with adherence challenges to care or medication and those with drug-resistant HIV. At-risk populations include men who have sex with men (MSM) including young men of color, transgender women (TGW), people who inject drugs (PWID) and African adolescent girls and women including those who are pregnant. We will enroll PWH at risk for comorbidities and PWH or without HIV with co-epidemic pathogens such as tuberculosis (TB) and Hepatitis B virus (HBV). We have skilled, experienced clinical and translational investigators working hand-in-hand with junior investigators with diversity of gender and race, in US and international settings, who will engage and execute the network scientific agenda. A globally representative set of senior scientists and public health leaders on our Scientific and Strategic Advisory Group advise the CTU leadership team. The CTU administration has a highly organized structure that is responsive to our research teams and CRSs. Each CRS engages the communities representing the affected populations in an interactive, open-minded way. State-of-art communication and experienced, outstanding and well-organized laboratory, pharmacy, regulatory, quality and data management support the CTU, CRSs. Using this robust framework the UNC Global CTU is positioned optimally to continue our scientific, and network leadership and clinical trials support to the agenda of all four NIH HIV networks.