PHASE III EVALUATION FOLLOWING NEONATAL HSV INFECTIONS INVOLVING THE CNS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究将评估口服阿昔洛韦对有或无扩散到其他器官(包括皮肤)的婴儿中枢神经系统疾病的长期抑制治疗的疗效。它将确定口服阿昔洛韦抑制疗法是否能改善单纯疱疹病毒病合并中枢神经系统受累的婴儿的神经学结果。此外，它还将讨论当所有其他脑脊液参数保持正常或显示改善时，脑脊液聚合酶链式反应(PCR)阳性结果的意义。将比较两组在出生后12个月内首次脑脊液聚合酶链式反应阳性的时间，结果将与临床神经学评估相关联。这项研究将确定持续口服阿昔洛韦混悬液是否能抑制单纯疱疹病毒病合并中枢神经系统受累的婴儿的复发皮损，并将证实在单纯疱疹病毒病合并中枢神经系统受累的婴儿中长期口服阿昔洛韦治疗的安全性。最后，将评估和量化阿昔洛韦抑制疗法对药物经济学和家庭基础设施问题的影响。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study will evaluate the efficacy of long-term suppressive therapy with oral acyclovir in infants with CNS disease, with or without evidence of dissemination to other organs (including the skin). It will determine if suppressive oral acyclovir therapy improves neurologic outcome in infants following HSV disease with CNS involvement. Also, it will address the significance of a positive CSF Polymerase Chain Reaction (PCR) result when all other CSF parameters either remain normal or show improvement. Comparisons will be made between groups with respect to post-randomization time to first positive CSF Polymerase Chain Reaction result during the initial 12 months of life, and results will be correlated with clinical neurological assessment. The study will determine if continuous administration of oral acyclovir suspension suppresses recurrent skin lesions in infants following HSV disease with CNS involvement, and it will confirm the safety of long-term administration of oral acyclovir therapy in a cohort of infants with HSV disease with CNS involvement. Finally, the effects of suppressive acyclovir therapy on issues of pharmacoeconomic and family infrastructure will be assessed and quantitated.