Women and Infants Transmission Study IV

妇女和婴儿传播研究(WITS)是一项全国性的、多中心的纵向观察队列研究，对感染HIV-1的孕妇及其婴儿进行研究，在过去十年中一直在招募患者。这项研究的总体目标是了解孕妇和婴儿、儿童和青少年中的HIV-1感染，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领导力和研究议程应用程序，将由六个独立的临床站点应用程序支持。领导和研究议程将确定WITS IV的研究目标、理由、研究结构和研究方法。申请的首席调查员将担任WITS执行委员会的主席，该委员会是WITS的管理机构。WITS IV的具体目标包括：1.确定抗逆转录病毒疗法(ART)时代婴儿、儿童和青少年中HIV-1感染的自然历史；2.确定非感染胎儿、婴儿、儿童和青少年暴露于ART的直接和远期影响；3.确定在ART时代孕期登记的HIV-1感染妇女的自然病史；4.检查坚持ART药物治疗、出现对ART耐药的HIV-1与儿科患者及其母亲的临床和治疗结果之间的关系；5.明确HIV-1感染孕妇中丙型肝炎病毒及HIV-1/丙型肝炎病毒混合感染的发病机制和自然病史，确定新感染丙型肝炎病毒的妇女队列，并探讨导致丙型肝炎病毒由母亲传染给婴儿的因素。这一应用程序将建立在WITS I-III中所做的研究的基础上，以检查在ART日益有效的时代艾滋病毒感染的变化情况。它将有助于深入了解围产期艾滋病毒-1感染的新时代以及预防和治疗感染的治疗的后果和挑战。

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.