The Malawi Clinical Trials Unit

描述（由申请人提供）： 本申请代表正在进行的马拉维艾滋病毒研究联盟（HRC）提交，该联盟包括马拉维医学院（COM）、北卡罗来纳州查佩尔山的北卡罗来纳州大学（北卡罗来纳州）和马里兰州巴尔的摩的约翰霍普金斯大学（JHU）彭博公共卫生学院。鉴于这些合作的悠久历史，JHU将继续作为主要受资助机构，并领导拟议的临床试验部门（CTU）的行政部门。这个全国性的联合体包括马拉维两个主要医疗设施的资源，即布兰太尔的伊丽莎白女王中央医院和利隆圭的Kamuzu中央医院（它们将代表临床研究地点）。 艾滋病毒/艾滋病的流行正在严重影响非洲儿童、青少年、男子和妇女的健康， 马拉维.在其中一些人群中，艾滋病毒流行率超过30%，艾滋病毒发病率超过每100人年4例。马拉维人权委员会开展了长期合作，重点是广泛的艾滋病毒研究，包括艾滋病毒预防、艾滋病毒治疗和护理以及新生疫苗工作的大部分方面。该联盟激发了几个尖端研究项目和非常广泛的培训和技术转让。 每个参与机构都为这一合作带来了必要的资源：马拉维的COM为成功的研究计划所需的卫生保健基础设施、适当的患者群体和国内人员的所有方面提供了关键的墨水;约翰霍普金斯大学提供了领导、培训、临床和实验室资源，以及导致创新干预措施的多样化科学研究议程;艾滋病毒/艾滋病研究所提供了接触新人口的机会，提高了生物研究能力，开创了性传播感染研究，并更加重视艾滋病毒治疗问题。 本提案的目的是：（一）在所有高度优先研究领域开展临床试验，评估适当干预措施的安全性、有效性和可接受性;（二）根据需要扩大到更多人群，以进一步研究艾滋病毒发病机制，评价适用于资源有限环境中人群的治疗和预防战略的制定，并应对新出现的科学机会;和III）与临床试验网络领导层合作，为科学议程做出贡献。 行政部门：

DESCRIPTION (provided by applicant): This application is submitted on behalf of the ongoing HIV Malawi HIV Research Consortium (HRC) which includes the College of Medicine (COM) in Malawi, the University of North Carolina (UNC) at Chapel Hill, NC and the Johns Hopkins University (JHU) Bloomberg School of Public Health in Baltimore, MD. In recognition of the long history of these collaborations, JHU will continue to serve as the primary grantee institution and lead the Administrative Component of the proposed Clinical Trials Unit (CTU). This country-wide consortium includes the resources of the two main medical facilities in Malawi, the Queen Elizabeth Central Hospital in Blantyre and the Kamuzu Central Hospital in Lilongwe (they will represent the Clinical Research Sites). The HIV/AIDS epidemic is severely impacting the health of children, adolescents, men and women in Malawi. In some of these populations, the HIV prevalence is more than 30% and HIV incidence is more than 4 per 100 person-years. The Malawi HRC has developed a long-term collaboration focused on a wide spectrum of HIV research that includes most aspects of HIV prevention, HIV treatment and care and nascent vaccine efforts. This consortium has inspired several cutting-edge research projects and very extensive training and technology transfers. Each participating institution brings essential resources to this collaboration: the COM in Malawi provides a critical ink to all aspects of the health care infrastructure, appropriate patient populations, and in-country personnel required for a successful research program; Johns Hopkins University has provided leadership, training, clinical and laboratory resources, and a diverse scientific research agenda that led to innovative interventions; and UNC has provided access to new populations, increased capacity for biological research, pioneered research on sexually transmitted infections, and increased focus on issues of HIV treatment. The Aims of this Proposal are I) To implement clinical trials that assess safety, efficacy and acceptability of appropriate interventions in all high priority research areas; II) To expand as needed to additional populations to further investigate HIV pathogenesis, evaluate the development of treatment and prevention strategies that are applicable to populations in resource-constrained settings, and respond to emerging scientific opportunities; and III) To work collaboratively with the Clinical Trials Networks Leadership to contribute to the scientific agenda. ADMINISTRATIVE COMPONENT: