HIGH DOSE ACYCLOVIR VERSUS VIDARABINE IN NEONATAL HERPES SIMPLEX INFECTION

高剂量阿昔洛韦与阿糖腺苷治疗新生儿单纯疱疹感染

• 批准号: 6303030
• 负责人: RICHARD J. WHITLEY
• 金额: $ 2.95万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6303030
• 关键词: Herpesviridae disease; acyclovir; central nervous system disorders; clinical research; clinical trial phase I; congenital infection; dosage; herpes simplex virus 1; human morbidity; human mortality; human subject; human therapy evaluation; microorganism disease chemotherapy; newborn human (0-6 weeks)

Specific objectives of this study are: 1) To determine whether high-dose acyclovir vs. vidarabine therapy 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). b) host antibody response (total HSV antibodies by ELISA and antibodies to specific polypeptides.) 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 high-dose acyclovir vs. vibaridine therapy 6) To determine whether antigens and antibodies specific for HSV glycoproteins within the CSF predict long-term neurologic outcome 7) To determine whether specific antigens and antibodies in the CSF appear late after treatment and are indicatiove of insidious reactivation of virus in the brain.

本研究的具体目标是： 1) 确定高剂量阿昔洛韦与阿糖腺苷治疗是否可以进一步降低中枢神经系统或播散性新生儿 HSV 感染的急性和长期随访的发病率和死亡率。 2) 为了确定高剂量阿昔洛韦化疗对新生儿是否安全和耐受，将监测以下内容 - a) 宿主功能的生化和骨髓参数（SGOT、BUN、肌酐、分类全血细胞计数、血小板计数和尿液分析）。 b) 宿主抗体反应（通过 ELISA 测定的 HSV 总抗体和针对特定多肽的抗体。） c) 急性和长期随访的不利影响。 3) 确定抗病毒药物是否产生耐药性 4) 扩大新生儿 HSV 感染婴儿的疾病分类，以预测预后 5) 确定高剂量阿昔洛韦与维巴定治疗中病毒排泄模式是否发生变化 6) 确定 CSF 内 HSV 糖蛋白特异性抗原和抗体是否可以预测长期预后 神经学结果 7) 确定脑脊液中的特异性抗原和抗体是否在治疗后出现较晚，并表明大脑中病毒的隐匿性重新激活。