CAPRISA Clinical Trials Unit for AIDS/Tuberculosis Prevention and Treatment

CAPRISA 艾滋病/结核病预防和治疗临床试验单位

• 批准号: 8609288
• 负责人: QUARRAISHA ABDOOL KARIM
• 金额: $ 369.74万
• 依托单位: CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8609288
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adult; Bioethics; Birth; Breast Feeding; Childhood; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Unit; Communication; Communication Tools; Communities; Conduct Clinical Trials; Data Quality; Decision Making; Enrollment; Ensure; Epidemic; Evaluation; Extreme drug resistant tuberculosis; Funding; Gel; Generations; Goals; Good Clinical Practice; HIV; Hospital Referrals; Housing; Immunity; Incidence; Laboratories; Leadership; Licensure; Multidrug-Resistant Tuberculosis; National Institute of Allergy and Infectious Disease; Newsletter; Occupational activity of managing finances; Participant; Patients; Persons; Pharmacy facility; Phase I Clinical Trials; Population; Prevalence; Prevention; Prevention strategy; Prophylactic treatment; Protocols documentation; Research; Research Infrastructure; Research Personnel; Research Support; Resources; Rural; Scientific Advances and Accomplishments; Services; Sexually Transmitted Diseases; South Africa; Structure; System; Tenofovir; Testing; Therapeutic; Training; Tuberculosis; Vaccines; Vertical Disease Transmission; Vision; Woman; clinical research site; cohort; data management; experience; high risk; hospital bed; innovation; medical schools; meetings; microbicide; neutralizing antibody; novel strategies; organizational structure; pediatric human immunodeficiency virus; programs; quality assurance; safety study; sound; symposium; transmission process; treatment center; treatment strategy; tuberculosis treatment; web site; young woman

DESCRIPTION (provided by the applicant): The CAPRISA Clinical Trials Unit for AIDS/Tuberculosis Prevention and Treatment (CAPRISA CTU), strategically located in KwaZulu-Natal, South Africa, at the epicenter of one of the world's most severe HIV and tuberculosis (TB) epidemics, has recently made significant scientific contributions on tenofovir gel and pre-exposure prophylaxis, HIV-TB treatment, prevention of breastfeeding transmission, and immunity with broadly neutralizing antibodies. The scientific team includes investigators who have served at the highest levels in Network leadership. During the current funding cycle, 2,854 participants have been enrolled in 25 protocols to date, with retention rates usually exceeding 90% and data quality scores exceeding 95%. The CAPRISA CTU comprises 4 components; firstly, experienced leadership, senior investigators and CTU coordinator; secondly, an administrative and governance component; thirdly, 10 research support cores; and fourthly, 4 Clinical Research Sites (CRSs). The eThekwini CRS for vaccine, microbicide and adult HIV treatment studies, is located in central Durban adjoining a local clinic that annually treats 40,000 patients with sexually transmitted infections (HIV prevalence of 59.3% (CI: 56.5-62.0) and HIV incidence rate of 6.4 per 100 person-years (CI: 2.6-13.2)) as well as 3,500 new TB cases, two thirds of whom are co-infected with HIV. At the rural Vulindlela CRS for integrated prevention, vaccine and microbicide studies, the HIV prevalence among young women is 35.7% (CI: 32.7-38.8) and the HIV incidence rate is 6.5 per 100 person-years (CI: 4.4-9.2). In this community, HIV incidence is 10.2 per 100 person-years (CI: 4.1-20.9) in women under 20 years. The Springfield CRS for adult HIV/TB treatment studies is located at a regional referral hospital that treated 2,359 MDR-TB and 206 XDR-TB patients (71% co-infected with HIV) in 2010. The Umlazi CRS for maternal/pediatric HIV studies is at a 1,200 bed hospital that provides pre-natal services to about 12,000 women annually (HIV prevalence: 39% (CI: 36.7-41.5)). The vertical transmission rate is 2.4% (CI 1.1-4.5) at birth but increases to 6.6% (CI 5.3-8.2) at 6-8 weeks post-partum due to breastfeeding. The CAPRISA CTU headquarters is located at the Nelson R Mandela School of Medicine and houses the Administration as well as the laboratory, pharmacy, data management and IT, community engagement, evaluation and quality assurance, financial management, bioethics, communication, regulatory compliance, and training Cores. The CTU's organizational structures (Leadership Group, Executive Committee and Community Advisory Board) and communication tools (regular meetings, video conferences, monthly newsletters and website) enable effective communication, management and governance in the unit. Overall, the CAPRISA CTU has diverse well-characterized high-risk populations, well established clinical facilities, accredited laboratories, pharmacies, and data management systems, strong community linkages, and extensive experience in conducting clinical trials, together with a track record of scientific innovation available to support the 5 Networks in developing new approaches to HIV and TB prevention and treatment.

描述（申请人提供）：CAPRISA艾滋病/结核病预防和治疗临床试验单位（CAPRISA CTU）位于南非夸祖鲁-纳塔尔的战略要地，是世界上最严重的艾滋病毒和结核病（TB）流行病之一的中心，最近在替诺福韦凝胶和暴露前预防、艾滋病毒-结核病治疗、预防母乳喂养传播、和广泛中和抗体的免疫力。科学团队包括曾在网络领导层担任过最高级别职务的调查人员。在当前的供资周期内，迄今已有2，854名参与者参加了25项方案，保留率通常超过90%，数据质量得分超过95%。CAPRISA CTU由4个组成部分组成：第一，经验丰富的领导层，高级研究人员和CTU协调员;第二，行政和治理部分;第三，10个研究支持核心;和第四，4个临床研究中心（CRS）。用于疫苗、杀微生物剂和成人艾滋病毒治疗研究的eThekwini CRS位于德班中部，毗邻一家当地诊所，该诊所每年治疗40，000名性传播感染患者（艾滋病毒流行率为59.3%（置信区间：56.5-62.0），艾滋病毒发病率为6.4/100人-年（CI：2.6-13.2））以及3，500例新的结核病病例，其中三分之二同时感染艾滋病毒。在Vulindlela农村社区研究中心进行的综合预防、疫苗和杀微生物剂研究中，年轻妇女的艾滋病毒流行率为35.7%（CI：32.7-38.8），艾滋病毒发病率为每100人年6.5人（CI：4.4-9.2）。在该社区，20岁以下妇女的艾滋病毒感染率为每100人年10.2例（CI：4.1-20.9）。Springfield CRS成人艾滋病毒/结核病治疗研究位于一家地区转诊医院，该医院在2010年治疗了2，359名耐多药结核病和206名广泛耐药结核病患者（71%合并感染艾滋病毒）。Umlazi儿童艾滋病毒研究中心设在一家拥有1 200张床位的医院，每年为约12 000名妇女提供产前服务（艾滋病毒流行率：39%（CI：36.7-41.5））。出生时的垂直传播率为2.4%（CI 1.1-4.5），但由于母乳喂养，产后6-8周时增加到6.6%（CI 5.3-8.2）。CAPRISA CTU总部位于纳尔逊·曼德拉医学院，设有行政部门以及实验室、药房、数据管理和IT、社区参与、评估和质量保证、财务管理、生物伦理、沟通、法规遵从性和培训核心。CTU的组织结构（领导小组、执行委员会和社区咨询委员会）和沟通工具（定期会议、视频会议、每月通讯和网站）使该单位能够进行有效的沟通、管理和治理。总体而言，CAPRISA CTU拥有各种特征鲜明的高危人群，完善的临床设施，认可的实验室，药房和数据管理系统，强大的社区联系，以及开展临床试验的丰富经验，以及可用于支持5个网络开发艾滋病毒和结核病预防和治疗新方法的科学创新记录。