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: 10304513
• 负责人: Joseph J Eron
• 金额: $ 110.93万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10304513
• 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; Color; 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; 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 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; virology; 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.

摘要 北卡罗来纳州大学（University of North Carolina）全球艾滋病预防和治疗临床试验部门 (CTU)具有良好的高质量，创新的临床研究，强大的网络记录 科学的领导力。反恐组与感染艾滋病的重要人群接触， 在美国东南部、南部非洲和东南亚的艾滋病毒高危人群中。我们的反恐小组由 三位经验丰富的主要研究者（Joseph Eron MD、Mina Hosseinipour MD和大卫 Wohl医学博士），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、疫苗预防和儿童、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）包括查佩尔山 由Wohl博士领导的CRS（成人策略、预防和疫苗CTN），格林斯伯勒CRS（成人 战略、预防和疫苗CTN），由马拉维CRS的Cornelius货车Dam医学博士领导（所有四个 CTN）由Lameck Chinula MD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新诊断的人（包括 急性感染），PWH稳定抑制治疗和PWH坚持治疗挑战 或者药物治疗和那些有抗药性的艾滋病病毒感染者。高危人群包括有性行为的男性 与男性（MSM），包括有色人种的年轻男性，跨性别女性（TGW）， 注射毒品和非洲少女和妇女，包括怀孕的少女和妇女。 我们将入组存在合并症风险的PWH和PWH或无HIV伴共流行病原体的PWH 如肺结核（TB）和B肝炎病毒（HBV）。我们有熟练的，经验丰富的临床和 翻译调查员与性别多样的初级调查员携手合作 在美国和国际环境中，谁将参与和执行网络科学 施政纲要的演讲一组具有全球代表性的高级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。反恐组的行政部门 有一个高度有组织的结构，是响应我们的研究团队和CRS。每个CRS 让代表受影响人口的社区参与互动， 路上了先进的沟通和经验丰富，优秀和组织良好的实验室， 药房、法规、质量和数据管理支持CTU、CRS。使用这个强大的 在这个框架下，全球CTU处于最佳位置，继续我们的科学和网络 领导和临床试验支持所有四个NIH艾滋病毒网络的议程。