PHASE III EVALUATION FOLLOWING NEONATAL HSV INFECTIONS INVOLVING THE CNS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究将评估口服阿昔洛韦长期抑制治疗有或没有证据表明传播到其他器官（包括皮肤）的中枢神经系统疾病婴儿的疗效。它将确定口服抑制性阿昔洛韦治疗是否能改善伴有中枢神经系统受损伤的HSV疾病后婴儿的神经系统预后。此外，当所有其他CSF参数保持正常或显示改善时，它将解决CSF聚合酶链反应（PCR）阳性结果的意义。各组之间将比较随机化后12个月内首次脑脊液聚合酶链反应阳性的时间，结果将与临床神经学评估相关。该研究将确定持续口服阿昔洛韦混悬液是否能抑制累及中枢神经系统的HSV疾病后婴儿皮肤病变复发，并将证实长期口服阿昔洛韦治疗累及中枢神经系统的HSV疾病婴儿队列的安全性。最后，将评估和量化阿昔洛韦抑制性治疗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.