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

北卡罗来纳大学全球艾滋病毒预防和治疗临床试验单位

• 批准号: 10600176
• 负责人: Joseph J Eron
• 金额: $ 35.66万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10600176
• 关键词: AIDS prevention; AIDS/HIV problem; Adherence; Adolescent; Adult; Affect; Africa; African; Area; Caring; Cells; Child; Childhood; Clinical; Clinical Investigator; Clinical Research; Clinical Treatment; Clinical Trials; Clinical Trials Network; Clinical Trials Support Unit; Clinical Trials Unit; Collaborations; Communication; Communities; Complex; Development; Disease remission; Doctor of Philosophy; Drug Kinetics; Drug resistance in tuberculosis; Enrollment; Epidemic; Female Adolescents; Goals; HIV; HIV Antibodies; HIV drug resistance; HIV vaccine; Hepatitis B; Hepatitis B Virus; Incidence; Individual; Infant; Injecting drug user; International; Intervention; Investigation; Laboratories; Lead; Leadership; Malawi; Mind; Mother-to-child HIV transmission; National Institute of Allergy and Infectious Disease; Newly Diagnosed; North Carolina; Nucleosides; Participant; Patient Recruitments; Persons; Pharmaceutical Preparations; Pharmacy facility; Phase; Population; Populations at Risk; Positioning Attribute; Pregnant Women; Prevention; Prevention trial; Principal Investigator; Public Health; Race; Recording of previous events; Research; Research Personnel; Risk; Sampling; Science; Scientist; Senior Scientist; Southeastern Asia; Southern Africa; Structure; Talents; Testing; Therapeutic; Therapeutic Clinical Trial; Tuberculosis; Tuberculosis Vaccines; United States National Institutes of Health; Universities; Vaccine Clinical Trial; Vaccines; Vietnam; Virus; Virus Activation; Work; acute infection; antiretroviral therapy; base; black women; clinical research site; co-infection; comorbidity; data management; early phase trial; experience; follow-up; gender diversity; high risk; high risk population; innovation; men of color; men who have sex with men; novel; pathogen; phase 3 study; pre-exposure prophylaxis; pregnant; prevention clinical trial; recruit; skills; transgender women; translational scientist; treatment as prevention; treatment trial; vaccine trial; viral rebound; virtual; volunteer; young man; young men who have sex with men; young woman

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.

抽象的 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、创新性临床研究记录、强大的网络 和科学领导。 CTU 与感染和感染病毒的极其重要的人群进行接触 美国东南部、非洲南部和东南亚地区是艾滋病毒高危地区。我们的 CTU 的领导者是 三位经验丰富的首席研究员（Joseph Eron MD、Mina Hosseinipour 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 策略、艾滋病毒预防、疫苗预防以及儿科、青少年和孕产妇 治疗策略。我们的四个经验丰富的临床研究中心 (CRS) 包括教堂山 CRS（成人策略、预防和疫苗 CTN）由 Greensboro CRS（成人）Wohl 博士领导 战略、预防和疫苗 CTN）由马拉维 CRS 医学博士 Cornelius Van Dam 领导（所有四名 CTN）由 Lameck Chinula 医学博士和越南 CRS（成人策略、预防和疫苗）领导 CTN）由 Vivian Go 博士领导。艾滋病毒感染者包括那些新诊断的人（包括患有艾滋病毒的人） 急性感染），PWH 治疗受到稳定抑制，PWH 面临护理依从性挑战 或药物治疗以及患有耐药性艾滋病毒的人。高危人群包括有性行为的男性 男性 (MSM)，包括年轻有色人种男性、变性女性 (TGW)、 注射毒品（注射吸毒者）和非洲少女和妇女，包括怀孕的妇女。 我们将招募有合并症风险的 PWH 和未感染 HIV 并伴有共流行病原体的 PWH 例如结核病（TB）和乙型肝炎病毒（HBV）。我们拥有技术精湛、经验丰富的临床和 转化研究者与不同性别的初级研究者携手合作 和种族，在美国和国际环境中，谁将参与和执行网络科学 议程。一组具有全球代表性的资深科学家和公共卫生领导人 科学和战略咨询小组为 CTU 领导团队提供建议。反恐联盟行政部门 拥有高度组织化的结构，能够响应我们的研究团队和 CRS。每个 CRS 让代表受影响人群的社区参与互动、思想开放的活动 方式。最先进的沟通和经验丰富、优秀且组织良好的实验室， 药学、监管、质量和数据管理支持 CTU、CRS。使用这种强大的 北卡罗来纳大学全球 CTU 的框架处于最佳位置，可以继续我们的科学和网络 对所有四个 NIH HIV 网络的议程提供领导和临床试验支持。