Stellenbosch University Clinical Trial Unit, Cape Town, South Africa

描述（由申请人提供）：拟定的斯泰伦博斯大学临床试验单位（SU CTU）位于南非开普敦的一家三级护理中心--泰格伯格学术医院。大都市地区艾滋病毒感染率很高（13%的妇女到产前诊所就诊），结核病发病率也很高（每100 000人新增病例超过600例）。 SU CTU有三个临床研究中心（CRS），以良好的整合方式运作，并建立了地区医院，社区卫生诊所和助产士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项儿科和1项PMTCT）。一项儿科研究确定了异烟肼预防结核病的作用（P1041）。预防母婴传播研究探讨了临产孕妇进行HIV检测的最佳时间（P1031）。两项研究将在过渡期招募超过每家临床试验机构每月平均20例患者的受试者。KIDCRU CRS计划进行两项额外的过渡研究：1。抗逆转录病毒（ARV）策略试验，这将为国家ARV计划提供关键信息（P390），2。青少年B型肝炎疫苗研究，这将为青少年研究计划（ATN 024）提供有用的信息和核心。KIDCRU CRS和PMTCT CRS已被邀请加入IMPAACT网络。SU CTU得到了来自SU健康科学学院的青少年，泌尿学，儿童结核病和儿科神经学专家顾问的支持，他们将为方案制定和研究实施做出贡献。第三个网站是成人传染病临床研究网站（AIDS CRS）。虽然尚未加入艾滋病毒/艾滋病网络，但其研究人员有为工业界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组分的试验。本CRS提出了一项针对接受结核病治疗的HIV阳性成人患者立即与延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单位ACTG的James McIntyre教授建立共同指导伙伴关系。通过这种共同指导的伙伴关系，艾滋病CRS预计将能够在六个月内招募受试者的资金。 行政部门：

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: