Women and Infants Transmission Study IV - Chicago

描述（由申请人提供）：妇女和婴儿传播研究 （WITS）是一项全国性、多中心、纵向观察性队列研究 HIV-1感染的孕妇及其婴儿， 近十年来，患者这项研究的总体目标是了解 孕妇、婴儿、儿童和青少年感染艾滋病毒-I， 以及抗逆转录病毒治疗的过程、反应、挑战和副作用 疗法此应用程序是WITS IV领导和研究议程 该应用程序将由六个独立的临床站点提供支持 应用.领导力和研究议程将确定研究目标， 理由，研究结构和研究方法为WITS IV。原则 申请的调查员将主持WITS执行委员会， WITS的管理机构。 WITS IV的具体目标包括：定义HIV-1的自然史 抗逆转录病毒时代婴儿、儿童和青少年的感染 治疗（ART）; 2.为了确定暴露于 未感染胎儿、婴儿、儿童和青少年的ART; 3.以限定 在怀孕期间登记的HIV-1感染妇女的自然史 艺术时代; 4.研究坚持抗逆转录病毒治疗与 药物治疗、出现抗逆转录病毒疗法的艾滋病毒感染者以及临床和 儿科患者及其母亲的治疗结果; 5.来定义 HIV-1中HCV和HIV-1/HCV共感染的发病机制和自然史 感染的孕妇，以确定一个队列的妇女与新的HCV感染， 并检查HCV传播的因素， 母亲对他们的婴儿。本申请将建立在 WITS 1-111研究了艾滋病毒感染的变化情况， 提高艺术的潜力。它将有助于深入了解 围产期HIV-1感染的新时代以及 治疗，以预防和治疗感染。

DESCRIPTION (provided by applicant): The Women and Infants Transmission Study (WITS) is a national, multi-center, longitudinal observational cohort study ofHIV-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 -I 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 I. To define the natural history of HIV-l infection in infants, children, and adolescents in an era of anti-retroviral 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-I infected women enrolled during pregnancy in the era of ART; 4. To examine the relationships between adherence to ART medication, emergence of HIV-I 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-l/HCV co-infection in HIV-l 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 1-111 to examine the changing landscape of HIV-l infection in eras of increasing potency of ART. It will contribute to an in-depth understanding of the new era of perinatal HIV-l infection and the consequence and challenges of therapy to prevent and treat the infection.