HIV PREVENTION TRIALS UNIT - MALAWI

据估计，全世界约有3100万成人和儿童感染了艾滋病毒，所有感染者中约有2100万人(68%)假定在撒哈拉以南非洲。据估计，全世界80%的女性艾滋病毒感染者都在撒哈拉以南非洲。在马拉维，艾滋病毒在孕妇中的流行率为30%，育龄妇女中艾滋病毒的发病率约为每100人年4例，婴儿死亡率超过每1000例活产100例。艾滋病毒母婴传播率约为28%。一些风险因素，如性传播疾病(STDS)，已被证明与艾滋病毒有关。迫切需要低成本、可持续和切实可行的干预措施。马拉维研究小组打算与艾滋病毒预防试验网络(HPTN)领导层和其他艾滋病毒预防试验单位(HPTU)调查人员密切合作，制定和实施研究方案，推动发展中国家和发达国家预防艾滋病毒的网络议程。约翰霍普金斯大学(JHU)、北卡罗来纳大学(UNC)-CH和马拉维大学医学院(COM)的合作在HPTN感兴趣的几乎所有研究领域为艾滋病毒预防做出了各种贡献。此外，通过HIVNET和其他来源，我们开发了资源和基础设施，以进行对新网络的成功至关重要的大型艾滋病毒干预试验。这项申请的具体目的是促进HPTN的研究，展示在马拉维进行艾滋病毒预防研究的能力，并根据需要扩大和纳入更多的人群，进行多项同时进行的疗效试验。JHU、UNC和马拉维COM的合作、调查人员的经验和他们从马拉维以前的工作中产生的研究结果，以及现有的基础设施，将有助于该网站为HPTN的研究和预防目标做出贡献。根据HPTN的研究方向，马拉维的研究人员成功地开展了围产期、杀微生物剂、性病、营养补充剂和其他研究。目前，两个主要的HIVNET第三阶段临床试验正在进行中，其中包括研究杀微生物剂N-9预防艾滋病毒和性传播疾病感染的有效性，以及围产期干预试验结合奈韦拉平和抗生素治疗绒毛膜羊膜炎的疗效。我们打算继续这些研究，并扩大到更多的地点。

About 31 million adults and children are estimated to have been infected with HIV worldwide, and about 21 million (68%) of all infections are assumed to be in sub-Saharan Africa. It is also estimated that 80% of all female HIV infections worldwide are in sub-Saharan Africa. In Malawi, the prevalence of HIV is 30% among pregnant women, the incidence of HIV is about 4 per 100 person-years among women of reproductive age, and infant mortality is more than 100 per 1000 live births. The rate of mother to child transmission of HIV is about 28%. Several risk factors such as sexually transmitted diseases (STDs) have been shown to be associated with HIV. Low-cost, sustainable, and practical intervention measures are urgently needed. The Malawi research team intends to work closely with the HIV Prevention Trials Network (HPTN) leadership and other HIV Prevention Trials Units (HPTUs) investigators to develop and implement research protocols which advance the network agenda of HIV prevention in developing and developed countries. The Johns Hopkins University (JHU), University of North Carolina (UNC)-CH, and College of Medicine (COM), University of Malawi collaboration has made a variety of contributions to HIV prevention in virtually all research areas of interest to the HPTN. In addition, through the HIVNET and other sources we have developed the resources and infrastructure to conduct large HIV intervention trials critical to the success of the new network. The specific aims of this application are to contribute to the HPTN research, to demonstrate the capability to conduct HIV prevention research in Malawi, and to expand and include additional populations as required for multiple, concurrent efficacy trials. The collaboration of JHU, UNC, and Malawi COM, the experience of the investigators and the research findings they have generated from previous work in Malawi, and the existing infrastructure, will serve the site to contribute to the HPTN research and prevention objectives. Consistent with the HPTN research direction, the Malawi investigators have carried out successful innovative perinatal, microbicide, STD, nutritional supplementation, and other studies. Currently, two major HIVNET phase III clinical trials involving a study on the effectiveness of the microbicide N-9 to prevent acquisition of HIV and STDS, and the efficacy of a perinatal intervention trial combining nevirapine and antibiotic treatment of chorioamnionitis are in progress. We intend to continue these studies and to expand to additional sites.