PHASE III EVALUATION FOLLOWING NEONATAL HSV INFECTIONS INVOLVING THE CNS

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项研究将评估长期口服阿昔洛韦抑制治疗婴儿中枢神经系统疾病的疗效，有或没有传播到其他器官（包括皮肤）的证据。 它将确定是否抑制性口服阿昔洛韦治疗改善神经系统的结果在婴儿以下HSV疾病与中枢神经系统的参与。 此外，当所有其他CSF参数保持正常或显示改善时，还将讨论阳性CSF聚合酶链反应（PCR）结果的意义。 在出生后最初12个月内，将比较两组间至首次阳性CSF聚合酶链反应结果的随机化后时间，并将结果与临床神经学评估相关联。 该研究将确定口服阿昔洛韦混悬液连续给药是否能抑制CNS受累的HSV疾病婴儿的复发性皮肤病变，并将证实长期口服阿昔洛韦治疗CNS受累的HSV疾病婴儿队列的安全性。 最后，将评估和量化抑制性阿昔洛韦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.