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中文摘要
翻译
临床核心将招募和跟踪生殖器HSV-2和生殖器HSV-1的研究参与者。 临床核心的具体目标是1)招募、筛选和登记以下研究方案的受试者 确定的人群;2)前瞻性地跟踪参与者的研究,保持对研究的密切关注 3)获取病毒学和免疫学实验室所需的临床标本 项目1和3中详述的调查,使用标准和专门技术。尤其是, 工作重点将集中在招募携带生殖器HSV-2的a)参与者,以实现项目1的具体目标, 包括HIV阴性、HIV阳性、孕妇和医源性免疫抑制者, 和c)感染生殖器单纯疱疹病毒2型的参与者,以实现项目3的具体目标。核心还将招聘 并跟踪参与者参加了检测抗病毒治疗对HSV重新激活的影响的研究 在艾滋病毒阴性和艾滋病毒阳性者中。对于项目2,临床核心将是新生儿 将对正在接受口服阿昔洛韦的患者进行评估和监测。 该中心位于华盛顿大学病毒学研究诊所(VRC)。VRC成立了 1974年成为研究单纯疱疹病毒感染的自然历史和治疗方法的中心。诊所也跟随着 >1000人首次出现生殖器疱疹,>3400人反复感染HSV-2。这个 临床率先使用每日生殖器拭子来评估HSV对粘膜的重新激活,并 描述HSV和HIV之间的粘膜相互作用。在过去的十年中,我们已经转向使用 单纯疱疹病毒DNA聚合酶链式反应用于病毒脱落的评估;使用这种方法,我们已经能够证明病毒 几乎在所有HSV血清阳性的人中都有脱落。其他已成为我们诊所标准程序的程序 包括生殖器病变活检和正常皮肤、直肠和宫颈活检、紫外线诱导生殖器 疱疹复发和白细胞分离,以进行宿主病毒的详细病毒学和免疫学研究 互动。参与详细病毒学和免疫学研究的参与者的宿主和病毒DNA都是 储存以备将来研究单纯疱疹病毒易感性、抵抗力和疾病严重程度的遗传决定因素 以及病毒测序工作。 临床核心致力于招募、筛选、招募和跟踪HSV感染者 感染到各种研究中。大多数人都会被跟踪一段时间,通常每天都会用棉签进行测量 皮肤和粘膜上病毒脱落的频率。此外,还有多种专业技术 可用。
英文摘要
The Clinical Core will enroll and follow study participants with genital HSV-2 as well as genital HSV-1 . Specific Aims of the Clinical Core is 1) to recruit, screen and enroll into research protocols subjects from defined populations; 2) to follow participants prospectively on studies, maintaining close adherence to study procedures, and 3) to obtain clinical specimens required for virologic and immunologic laboratory investigations detailed in Projects 1 and 3, using both standard and specialized techniques. In particular, the efforts will focus on enrolling a) participants with genital HSV-2 to address the specific aims of Project 1, including both HIV negative, HIV positive, pregnant women, and those with iatrogenic immunosuppression, and c) participants with genital HSV-2 to address the specific aims of Project 3. The core will also recruit and follow participants enrolled into studies examining the effect of antiviral therapy on HSV reactivation both in HIV negative and HIV positive persons. For project 2, the Clinical Core will be a site where the neonates who are receiving oral acyclovir will be evaluated and monitored. The Core is located at the University of Washington Virology Research Clinic (VRC). The VRC was founded in 1974 as a center for studies of natural history and therapeutics of HSV infections. The clinic has followed >1000 persons with first episode of genital herpes and >3400 persons with recurrent HSV-2 infection. The clinic has pioneered the use of daily genital swabs to evaluate the reactivation of HSV on mucosa, and to characterize the mucosal interactions between HSV and HIV. In the last decade, we have moved to using HSV DNA PCR for evaluation of viral shedding; using this method, we have been able to demonstrate viral shedding in almost all HSV seropositive persons. Other procedures that have become standard in our clinic include biopsies of genital lesions and normal skin, rectal and cervical biopsies, UV light induction of genital herpes recurrences, and leukapheresis for detailed virologic and immunologic studies of host-virus interactions. Both host and viral DNA of participants in the detailed virologic and immunologic studies are stored for future investigations of genetic determinants of HSV susceptibility, resistance and disease severity as well as viral sequencing work. The Clinical Core is dedicated to recruiting, screening, enrolling and following persons who have HSV infections into a variety of studies. Most persons are followed over time, often with daily swabs to measure the frequency of viral shedding on the skin and mucosa. In addition, a variety of specialized techniques are available.
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Administrative Core
  • 批准号:
    9982771
  • 项目类别:
  • 资助金额:
    $45.54万
  • 财政年份:
    2019
  • 负责人:
    Anna Wald
  • 依托单位:
海外基金