Johns Hopkins University Kampala-Nanning Clinical Trial Unit

约翰霍普金斯大学坎帕拉-南宁临床试验中心

• 批准号: 8609688
• 负责人: MARY Glenn Fowler
• 金额: $ 315.06万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-05 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8609688
• 关键词: AIDS prevention; AIDS/HIV problem; Adherence; Adolescent; Adult; Affect; Anti-Retroviral Agents; Baltimore; Behavioral; Breast Feeding; Child; Childhood; China; Clinic; Clinical Protocols; Clinical Research; Clinical Trials Network; Clinical Trials Unit; Collaborations; Communicable Diseases; Communities; Conduct Clinical Trials; Country; Couples; Data; Drug Kinetics; Enrollment; Family; Foundations; Grant; HIV; HIV Infections; HIV prevention trial; Hepatitis B Virus; Hepatitis C virus; High Risk Woman; Immune; Infant; Infection; Injecting drug user; Institutes; International; Lead; Leadership; Link; Manuscripts; Medicine; Mentors; Morbidity - disease rate; Mothers; New Agents; Nurses; Oral; Participant; Performance; Pharmaceutical Preparations; Pharmacists; Phase; Population; Populations at Risk; Postpartum Women; Pregnant Women; Prevention; Primary Prevention; Prophylactic treatment; Regimen; Research; Research Personnel; Research Support; Risk; Role; Safety; Site; Structure; Therapeutic; Therapeutic Clinical Trial; Training; Treatment Protocols; Tuberculosis Vaccines; Uganda; United States National Institutes of Health; Universities; Vaccines; Vertical Disease Transmission; Woman; Work; Writing; base; clinical research site; cohort; college; design; follow-up; high risk; immunogenicity; improved; microbicide; mortality; novel; novel strategies; pregnant; prevent; professor; transmission process; treatment trial; tuberculosis drugs; tuberculosis treatment; uptake; vaginal microbicide; virtual

DESCRIPTION (provided by applicant): We propose to establish a Johns Hopkins (JHU) Clinical Trial Unit (CTU) with three affiliated Clinical Research sites (CRS): two in Kampala, Uganda, and one in Manning, China. The proposed CTU structure includes joining of two CTU leaderships and clinical research sites with outstanding performance over the past grant cycle. The successful performance includes high enrollment of over 3700 participants and retention rates between 83% and 97%; a consistent track record as the leader of network scientific contributions; and successful conduct of high priority HIV Prevention and Therapeutic clinical trials within three of the current NIH HIV Clinical Trial Networks. The Johns Hopkins Kampala -Nanning (K-N) CTU proposal will be led by two PD/PIs, Professors Mary Glenn Fowler and Brooks Jackson, who have worked collaboratively in various roles over the past 22 years to conduct clinical trials on HIV prevention and HIV therapeutics and its complications. This CTU will have its central administrative base at JHU in Baltimore, MD and will conduct the network HIV clinical protocols at two CRSs in Kampala, Uganda and one CRS in Nanning, China. 1. The Makerere U. Johns Hopkins U. Research Collaboration (MU-JHU) CRS will be affiliated with a) the Clinical Research Network for HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations focusing on PMTCT and treatment of HIV infected infants and young children; b) the Network on Integrated Strategies to Prevent HIV Infection; and c) the Network on Microbicides to Prevent HIV Infection. 2. The Pediatric Infectious Diseases Clinic/ Baylor College of Medicine Children's Foundation of Uganda Institute (PIDC) CRS, an independent nonprofit NGO entity in Uganda will focus on pediatric and adolescent HIV treatment trials and will be affiliated with the Network on Infections in Pediatric and Maternal Populations. 3. The Nanning CRS site in Nanning China will be affiliated with a) the Network for HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations focusing on PMTCT and treatment of HIV infected infants and young children; b) the Network on Integrated Strategies to Prevent HIV Infection; and c) the Network on Therapeutics for HIV and associated infections.

描述（由申请人提供）：我们提议建立一个约翰霍普金斯（JHU）临床试验单位（CTU），下设三个临床研究中心（CRS）：两个在乌干达坎帕拉，一个在中国曼宁。拟议的CTU结构包括加入两个CTU领导层和在过去的资助周期中表现出色的临床研究中心。成功的表现包括超过3700名参与者的高入组率和83%至97%的保留率;作为网络科学贡献的领导者的一贯记录;以及在目前的三个NIH HIV临床试验网络中成功进行高优先级的HIV预防和治疗临床试验。约翰霍普金斯坎帕拉-南宁（K-N）CTU提案将由两名PD/PI领导，玛丽格伦福勒教授和布鲁克斯杰克逊教授，他们在过去22年中以各种角色合作开展艾滋病毒预防和艾滋病毒治疗及其并发症的临床试验。该CTU将在马里兰州巴尔的摩的JHU设立中央行政基地，并将在乌干达坎帕拉的两个CRS和中国南宁的一个CRS实施网络艾滋病毒临床协议。 1. Makerere U.约翰霍普金斯大学研究合作（MU-JHU）CRS将隶属于 a）儿科艾滋病毒/艾滋病和艾滋病毒相关感染临床研究网络， 侧重于防止母婴传播和治疗感染艾滋病毒的婴幼儿的孕产妇群体; B）预防艾滋病毒感染综合战略网络;以及c）预防艾滋病毒感染杀微生物剂网络。 2.儿科传染病诊所/贝勒医学院儿童基金会 乌干达研究所（PIDC）CRS是乌干达的一个独立的非营利非政府组织实体，将专注于儿童和青少年艾滋病毒治疗试验，并将与感染网络建立联系 在儿科和孕产妇人群中。 3.在中国南宁的南宁天主教救济会网站将附属于a）艾滋病毒/艾滋病网络， 儿童和孕产妇人群中与艾滋病毒有关的感染，重点是防止母婴传播和治疗感染艾滋病毒的婴幼儿; B）预防艾滋病毒感染综合战略网络;以及c）艾滋病毒和相关感染治疗网络。