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部门 （CTU）拥有高质量，创新临床研究的良好记录，强大的网络 和科学领导。 CTU参与感染和 美国东南部，南部非洲和东南亚的HIV风险很高。我们的CTU由 三名经验丰富的首席调查员（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，预防艾滋病毒，预防疫苗和小儿，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网站（CRS）包括教堂山 CRS（成人策略，预防和疫苗CTN）由Wohl博士，Greensboro CRS（成人）领导 策略，预防和疫苗CTN）由Cornelius Van Dam MD，马拉维CRS（全部四个） CTN）由Lameck Chinula MD和越南CR（成人策略，预防和疫苗）领导 CTN）由Vivian Go PhD领导。艾滋病毒的参与者包括那些新诊断的参与者（包括 急性感染），PWH在治疗和PWH上稳定抑制，并遵守挑战 或药物以及患有抗药性艾滋病毒的患者。处于危险的人群包括性爱的男人 与男人（MSM），包括有色人种，变性女性（TGW）， 注射毒品（PWID）和非洲青少年女孩和妇女在内，包括怀孕的女孩。 我们将招募有合并症的PWH风险，而没有艾滋病毒的PWH风险 例如结核病（TB）和丙型肝炎病毒（HBV）。我们有熟练，经验丰富的临床和 转化调查人员与性别多样性的初级调查员携手合作 在美国和国际环境中的种族将参与和执行网络科学 议程。全球代表的高级科学家和公共卫生领导者 科学和战略咨询小组建议CTU领导团队。 CTU管理 具有高度组织的结构，对我们的研究团队和CRS有响应。每个CRS 与代表受影响人群的社区参与互动，开放的思想 方式。最先进的沟通以及经验丰富，出色且组织良好的实验室， 药房，监管，质量和数据管理支持CTU，CRS。使用这种强大的 框架UNC Global CTU在继续我们的科学和网络方面处于最佳位置 领导力和临床试验支持所有四个NIH HIV网络的议程。