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: 8211839
• 负责人: Mark Fredric Cotton
• 金额: $ 163.12万
• 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 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8211839
• 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 Unit; Colorado; Communicable Diseases; Community Health; Discipline of obstetrics; Enrollment; Faculty; Funding; HIV; Health Sciences; Hepatitis B Vaccines; High Prevalence; Hospitals; Human immunodeficiency virus test; IMPAACT; Incidence; Industry; 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StellenBosch大学临床试验中心(SU CTU)位于南非开普敦的泰格伯格学术医院，这是一家三级护理中心。大都市地区的艾滋病毒流行率很高(13%的妇女在产前诊所就诊)，结核病的发病率也很高(每10万人中有600例新发病例)。 SU CTU有三个临床研究站点(CRS)，它们以良好的整合方式运作，并建立了来自地区医院、社区卫生诊所和中产产科单位的转诊系统。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小组(PACTG)建立的，目前招募受试者参加三项过渡研究(2名儿科和1名母婴传播)。一项儿科研究确定了异烟肼在预防结核病中的作用(P1041)。防止母婴传播研究解决了临产孕妇进行艾滋病毒检测的最佳时间(P1031)。这两项研究都将在过渡阶段增加受试者，超过每个地点平均每月20名患者的要求。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，这将为国家ARV计划(P390)提供关键信息；2.青少年乙肝疫苗研究，这将为青少年研究计划(ATN024)提供有用的信息和核心。KIDCRU CRS；和防止母婴传播CRS已被邀请加入综合防灾中心网络。SU CTU得到了SU健康科学学院青春期、新生儿、儿童结核病和儿科神经学方面的专家顾问的支持，他们将为方案的制定和研究的实施做出贡献。第三个站点是成人传染病临床研究站点(AIDS CRS)。虽然还没有隶属于艾滋病毒/艾滋病网络，但其调查人员有为工业进行抗逆转录病毒试验和启动两种非核苷逆转录酶抑制剂作为抗逆转录病毒疗法第三组分的试验的记录。这项CRS提出了一项针对HIV+成人结核病患者立即开始抗逆转录病毒治疗与推迟开始抗逆转录病毒治疗的优化研究(AACTG A5221)。将与科罗拉多大学科罗拉多艾滋病CTU的托马斯·坎贝尔博士和威特沃特斯兰德大学围产期艾滋病毒研究部的詹姆斯·麦克泰尔教授建立共同指导伙伴关系。通过这种共同指导伙伴关系，预计艾滋病研究报告中心将能够在获得资金后的六个月内招收受试者。 管理组件：

项目成果

The where, when, and how of community-based versus clinic-based ART delivery in South Africa and Uganda.

• DOI: 10.1016/s2214-109x(20)30385-5
• 发表时间: 2020-10
• 期刊: The Lancet. Global health
• 作者: Nachega JB;Fatti G;Zumla A;Geng EH
• 通讯作者: Geng EH

The determination of capreomycin in human plasma by LC-MS/MS using ion-pairing chromatography and solid-phase extraction.

使用离子对色谱和固相萃取，通过 LC-MS/MS 测定人血浆中的卷曲霉素。

• DOI: 10.1002/bmc.4269
• 发表时间: 2018
• 期刊: Biomedical chromatography : BMC
• 作者: Thuboy,Blessings;Kellermann,Tracy;Castel,Sandra;Norman,Jennifer;Joubert,Anton;Garcia-Prats,AnthonyJ;Hesseling,AnnekeC;Wiesner,Lubbe
• 通讯作者: Wiesner,Lubbe

LIPODYSTROPHY SYNDROME IN HIV-INFECTED CHILDREN ON HAART.

接受 HAART 治疗的 HIV 感染儿童的脂肪营养不良综合征。

• DOI: 10.4102/sajhivmed.v10i4.264
• 发表时间: 2009
• 期刊: Southern African journal of HIV medicine
• 影响因子: 1.7
• 作者: Innes,Steve;Levin,Leon;Cotton,Mark
• 通讯作者: Cotton,Mark