Women and Infants Transmission Study IV

妇女和婴儿传播研究（WITS）是一项针对HIV-1感染孕妇及其婴儿的全国性、多中心、纵向观察队列研究，该研究在过去十年中一直在招募患者。该研究的总体目标是了解孕妇、婴儿、儿童和青少年的HIV-1感染情况，以及抗逆转录病毒治疗的过程、反应、挑战和副作用。该应用程序是WITS IV领导和研究议程应用程序，它将由六个独立的临床站点应用程序支持。领导和研究议程将定义WITS IV的研究目标、理由、研究结构和研究方法。申请的主要研究者将主持WITS执行委员会，即WITS的管理机构。WITS IV的具体目标包括：1。定义抗逆转录病毒治疗（ART）时代婴儿、儿童和青少年HIV-1感染的自然历史；2. 确定接触抗逆转录病毒药物对未感染胎儿、婴儿、儿童和青少年的即时和后期影响；3. 确定在抗逆转录病毒治疗时代登记的怀孕期间感染艾滋病毒1型妇女的自然历史；4. 研究儿科患者及其母亲坚持抗逆转录病毒药物治疗、HIV-1耐药的出现与临床和治疗结果之间的关系；5. 明确HIV-1感染孕妇中HCV和HIV-1 /HCV合并感染的发病机制和自然史，确定一组新发HCV感染的妇女，并研究母亲将HCV传播给婴儿的因素。该应用程序将建立在WITS I-III研究的基础上，以检查在抗逆转录病毒治疗效力增强的时代HIV-1感染的变化情况。它将有助于深入了解围产期HIV-1感染的新时代以及预防和治疗感染的后果和挑战。

The Women and Infants Transmission Study (WITS) is a national, multi-center, longitudinal observational cohort study of HIV-1 infected pregnant women and their infants that has been enrolling patients for the last decade. The overall goal of the study is to understand HIV-1 infection in pregnant women and in infants, children and adolescents, and the course, response, challenges, and side effects of antiretroviral therapy. This application is the WITS IV Leadership and Research Agenda application, which will be supported by six separate clinical site applications. The Leadership and Research Agenda will define the study aims, justification, study structure, and study approach for WITS IV. The Principle Investigator of the application will chair the WITS Executive Committee, the governing body of WITS. The Specific Aims for WITS IV include 1. To define the natural history of HIV-1 infection in infants, children, and adolescents in an era of antiretroviral therapy (ART); 2. To determine the immediate and late effects of exposure to ART in uninfected fetuses, infants, children, and adolescents; 3. To define the natural history of HIV-1 infected women enrolled during pregnancy in the era of ART; 4. To examine the relationships between adherence to ART medication, emergence of HIV-1 resistant to ART, and the clinical and treatment outcome in pediatric patients and their mothers; 5. To define the pathogenesis and natural history of HCV and HIV- 1/HCV co-infection in HIV-1 infected pregnant women, to identify a cohort of women with new HCV infection, and to examine the factors responsible for the transmission of HCV from mothers to their infants. This application will build on the studies done in WITS I-III to examine the changing landscape of HIV-1 infection in eras of increasing potency of ART. It will contribute to an in-depth understanding of the new era of perinatal HIV-1 infection and the consequence and challenges of therapy to prevent and treat the infection.