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

基本信息

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
项目类别：
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

项目摘要

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（由申请人提供）：艾滋病/结核病预防和治疗的CAPRISA临床试验单位（CAPRISA CTU），位于南非夸祖鲁 - 纳塔尔省，在世界上最严重的HIV HIV和HIV和结核病（TB）的Pretexis prectib and ten speremiss Precovir and ten comporifir proments of ten spermiss pronsiral and ten inser prectir promistir promister and caprisa ctu（Caprisa ctu），在南非的夸祖鲁 - 纳塔尔省（Kwazulu-natal），上的中心。 HIV-TB治疗，预防母乳喂养传播以及具有广泛中和抗体的免疫力。科学团队包括在网络领导力最高水平的调查人员。在当前的融资周期中，迄今为止，已有252个参与者招募了25个协议，保留率通常超过90％，数据质量评分超过95％。 Caprisa CTU包含4个组件；首先，经验丰富的领导力，高级调查员和CTU协调员；其次，行政和治理部分；第三，10个研究支持核心；第四，有4个临床研究地点（CRS）。 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其中三分之一与艾滋病毒共同感染。在用于综合预防，疫苗和杀生型研究的农村vulindlela CR中，年轻女性的HIV患病率为35.7％（CI：32.7-38.8），HIV发病率为每100人年6.5（CI：4.4-9.2）。在这个社区中，20岁以下女性的艾滋病毒发病率为每100人年10.2（CI：4.1-20.9）。成人HIV/TB治疗研究的Springfield CR位于2010年治疗2,359名MDR-TB和206名XDR-TB患者（71％与HIV共同感染的71％）的区域转诊医院。在1,200床医院提供了1,200床医院，可为纳塔尔妇女提供1,200次床位的umlazi crs（39％）。 36.7-41.5））。出生时，垂直传输率为2.4％（CI 1.1-4.5），但由于母乳喂养而导致的香气后6-8周增加到6.6％（CI 5.3-8.2）。 CAPRISA CTU总部位于纳尔逊R Mandela医学院，并在政府以及实验室，药房，数据管理以及IT，社区参与，评估和质量保证，财务管理，生物伦理学，交流，法规，法规合规和培训核心。 CTU的组织结构（领导力小组，执行委员会和社区顾问委员会）和沟通工具（常规会议，视频会议，每月新闻通讯和网站）可以在该部门中有效的沟通，管理和治理。总体而言，CAPRISA CTU具有多样化的高风险人群，建立良好的临床设施，经过认可的实验室，药房和数据管理系统，牢固的社区联系以及进行临床试验的丰富经验，以及可用于支持HIV和TB Presention和TB Presention和TB Presention和TB Presention和TB Presention和TB Presention the New Network的科学创新记录。