Stellenbosch University Clinical Trial Unit, Cape Town, South Africa

斯泰伦博斯大学临床试验中心，南非开普敦

• 批准号: 7097842
• 负责人: Mark Fredric Cotton
• 金额: $ 167.84万
• 依托单位: STELLENBOSCH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-15 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7097842
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adolescence; Adolescent; Adult; Anti-Retroviral Agents; Cell Nucleus; Child; Childhood; Clinic; Clinical Trials; Colorado; Communicable Diseases; Community Health; Community Hospitals; Discipline of obstetrics; Enrollment; Faculty; Funding; HIV; Health Sciences; Hepatitis B Vaccines; High Prevalence; Hospitals; Human immunodeficiency virus test; Incidence; Industry; International Maternal Pediatric Adolescent AIDS Clinical Trials Group; Mentors; Neonatology; Patients; Pediatric Neurology; Perinatal; Phase Transition; Population; Pregnant Women; Prevention; Recruitment Activity; Research; Research Personnel; Role; Site; South Africa; System; Time; Tuberculosis; Universities; Vertical Disease Transmission; Wife; Woman; antiretroviral therapy; clinical research site; isoniazid; metropolitan; non-nucleoside reverse transcriptase inhibitors; pediatric AIDS; prevent; programs; protocol development; tertiary care; trial comparing

DESCRIPTION (provided by applicant): The proposed Stellenbosch University Clinical Trial Unit (SU CTU) is located at Tygerberg Academic Hospital, a tertiary care centre in Cape Town, South Africa. The metropolitan region has a high prevalence of HIV (13% of women attending antenatal clinics) and also a high incidence of tuberculosis (>600 new cases/100 000 population). The SU CTU has three Clinical Research Sites (CRS) that operate in a well integrated fashion and an established referral system from regional hospitals, community health clinics and mid-wife obstetric units. The Children's Infectious Diseases (KIDCRU) CRS and the Prevention of Mother-to-Child Transmission (PMTCT) CRS were established through the Pediatric AIDS Clinical Trial Group (PACTG) and presently recruiting subjects into three transition studies (2 pediatric and 1 PMTCT). One pediatric study determines the role of isoniazid in preventing tuberculosis (P1041). The PMTCT study addresses the optimal time for HIV testing for pregnant women presenting for labor (P1031). Both studies will accrue subjects in the transition phase in excess of the 20 patient average per month required for each site. The KIDCRU CRS is planning two additional transition studies: 1. Antiretroviral (ARV) strategy trial which will provide critical information for the national ARV program (P390) and, 2. Hepatitis B vaccine study for adolescents, which will provide useful information and a nucleus for an adolescent research program (ATN024). The KIDCRU CRS; and PMTCT CRS have been invited to affiliate with the IMPAACT Network. The SU CTU has the support of expert consultants in adolescence, neonatology, childhood TB and pediatric neurology from the SU Faculty of Health Sciences, who will contribute to protocol development and study implementation. The third site is an Adult infectious Diseases Clinical Research Site (AIDs CRS). Although not yet affiliated with a HIV/AIDS network, its investigators have a track record of conducting ARV trials for industry and initiating a trial comparing two non-nucleoside reverse transcriptase inhibitors as a third component of ARV therapy. This CRS proposes an optimization study of immediate versus deferred initiation of antiretroviral therapy for HIV+ adults treated for tuberculosis (AACTG A5221). A co-mentoring partnership will be established with Dr. Thomas Campbell from the Colorado AIDS CTU, University of Colorado, and Prof. James Mclntyre, Perinatal HIV Research Unit ACTG, Witwatersrand University. Though this co-mentoring partnership, the AIDs CRS is expected to be able to enroll subjects within six months of funding. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：拟建的斯泰伦博斯大学临床试验中心 (SU CTU) 位于南非开普敦的三级护理中心 Tygerberg 学术医院。大都市区的艾滋病毒患病率很高（13%的妇女去产前诊所就诊），结核病发病率也很高（每 10 万人口新增病例超过 600 例）。 SU CTU 拥有三个以良好整合方式运作的临床研究中心 (CRS)，以及由地区医院、社区卫生诊所和助产士产科单位建立的转诊系统。儿童传染病 (KIDCRU) CRS 和预防母婴传播 (PMTCT) CRS 是通过儿科艾滋病临床试验组 (PACTG) 建立的，目前正在招募受试者参加三项过渡研究（2 项儿科研究和 1 项 PMTCT）。一项儿科研究确定了异烟肼在预防结核病中的作用 (P1041)。 PMTCT 研究探讨了临产孕妇进行 HIV 检测的最佳时间 (P1031)。这两项研究将在过渡阶段招募超过每个中心每月平均 20 名患者的受试者。 KIDCRU CRS 正在计划另外两项过渡研究：1. 抗逆转录病毒 (ARV) 策略试验，将为国家 ARV 计划 (P390) 提供关键信息；2. 青少年乙型肝炎疫苗研究，它将提供有用的信息和核心信息青少年研究计划（ATN024）。 KIDCRU CRS；和 PMTCT CRS 已受邀加入 IMPAACT 网络。 SU CTU 得到了 SU 健康科学学院青春期、新生儿学、儿童结核病和儿科神经病学专家顾问的支持，他们将为方案制定和研究实施做出贡献。第三个站点是成人传染病临床研究站点（AIDs CRS）。尽管尚未隶属于艾滋病毒/艾滋病网络，但其研究人员拥有为行业进行抗逆转录病毒试验的记录，并启动了一项比较两种非核苷逆转录酶抑制剂作为抗逆转录病毒治疗第三种成分的试验。该 CRS 提出了一项针对接受结核病治疗的 HIV + 成人立即与延迟开始抗逆转录病毒治疗的优化研究 (AACTG A5221)。我们将与科罗拉多大学科罗拉多艾滋病 CTU 的 Thomas Campbell 博士和威特沃特斯兰德大学围产期艾滋病毒研究中心 ACTG 的 James Mclntyre 教授建立共同指导伙伴关系。通过这种共同指导伙伴关系，艾滋病 CRS 预计能够在资助后六个月内招募受试者。 行政部分：