HIGH DOSE GANCICLOVIR(DHPG) FOR SYMPTOMATIC CONGENITAL CYTOMEGALOVIRUS INFECTION

高剂量更昔洛韦 (DHPG) 治疗有症状的先天性巨细胞病毒感染

• 批准号: 6244068
• 负责人: RICHARD J. WHITLEY
• 金额: $ 2.46万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-10 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6244068
• 关键词: Herpesviridae disease; acyclovir; central nervous system disorders; clinical research; congenital infection; cytomegalovirus; dosage; enzyme linked immunosorbent assay; ganciclovir; herpes simplex virus 1; host organism interaction; human morbidity; human mortality; human subject; microorganism disease chemotherapy; newborn human (0-6 weeks); prognosis

Neonatal herpes simplex virus (HSV) infection can be a life threatening disease associated with high mortality and morbidity. Infection of the newborn with HSV is usually the consequence of intrapartum contact with infected maternal genital secretions. Infection can also be transmitted in utero or, infrequently, as a consequence of postnatal acquisition of HSV-1 by contact with infected individuals. We hypothesize that the treatment with high dose acyclovir will decrease mortality and morbidity of CNS or disseminated neonatal HSV infection. Specific aims of this protocol are: 1) To determine whether high dose acyclovir can further decrease morbidity and mortality of CNS or disseminated neonatal HSV infection both acutely and on long-term follow-up. 2) To determine if high dose acyclovir chemotherapy is safe and tolerated in the newborn, the following will be monitored: a) biochemical and bone-marrow parameters of host function (SGOT, BUN, Creatinine, CBC with differential, platelet count, and urinalysis, etc.); b) host antibody response (total HSV antibodies by ELISA and antibodies to specific polypeptides); and c) adverse effects both acutely and on long-term follow-up. 3) To determine if resistance to antiviral medication develops. 4) To amplify disease classification for babies with neonatal HSV infection for purposes of predicting prognosis. 5) To determine whether there is a change in viral excretion patterns in patients receiving high dose acyclovir. 6) To determine whether HSV-DNA in the CSF predicts long-term neurologic outcome. 7) To determine whether specific HSV DNA in the CSF following completion of treatment is indicative of insidious reactivation of virus in the brain.

新生儿单纯疱疹病毒（HSV）感染可能是威胁生命的 与高死亡率和发病率相关的疾病。 感染 带有HSV的新生儿通常是与原始接触的结果 感染的产妇分泌物。 感染也可以传播 在子宫内，由于产后收购而很少 HSV-1通过与受感染的个体接触。 我们假设 高剂量的acyclovir治疗将降低死亡率和发病率 中枢神经系统或传播新生儿HSV感染。 特定目的 协议是：1）确定是否可以进一步 降低CNS或传播新生儿HSV的发病率和死亡率 急性感染和长期随访。 2）确定是否 高剂量的acyclovir化学疗法在新生儿中是安全且耐受性的 将监视以下内容：a）生化和骨ro 主机功能的参数（SGOT，BUN，肌酐，CBC 差分，血小板计数和尿液分析等）； b）宿主抗体 响应（ELISA的总HSV抗体和特定的抗体 多肽）; c）急性和长期不利影响 后续。 3）确定抗病毒药物的耐药性是否 发展。 4）扩大新生儿婴儿的疾病分类 HSV感染是为了预测预后。 5）确定 患者的病毒排泄模式是否发生变化 接受高剂量的acyclovir。 6）确定HSV-DNA是否在 CSF预测了长期神经系统结果。 7）确定是否 治疗完成后CSF中的特定HSV DNA为 指示大脑中病毒的阴险重新激活。