PHASE III EVALUATION FOLLOWING NEONATAL HSV LIMITED TO THE SKIN, EYE AND MOUTH

这个子项目是许多研究子项目中的一个 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。 本研究将评估长期口服阿昔洛韦抑制治疗局限于皮肤、眼睛和口腔的HSV感染婴儿的疗效。 SEM将确定口服阿昔洛韦治疗是否改善SEM疾病后婴儿的神经功能结局。 基于来自早期CASG研究的数据，选择神经学结果的评估作为主要研究终点，该研究发现，当在12个月时测量时，在出生后的前6个月内在SEM婴儿中发生的>3次皮肤复发与异常神经学结果相关。 提示这组婴儿可能发生CNS内HSV亚临床再激活。 因此，系统研究抑制性阿昔洛韦，以防止这种假定的亚临床中枢神经系统再激活，从而改善神经系统的结果在12个月龄是本调查的主要目标。 本研究将讨论当所有其他CSF参数保持正常时，脑脊液PCR阳性结果的意义。 在出生后最初12个月内，将对随机化后至首次脑脊液PCR阳性结果的时间进行组间比较，并将结果与临床神经系统评估相关联。 该研究将确定连续口服阿昔洛韦混悬液是否能抑制SEM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SEM疾病婴儿的安全性。 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 HSV infection limited to the skin, eyes and mouth. SEM will determine if oral acyclovir therapy improves neurologic outcome in infants following SEM disease. Assessment of neurologic outcome was chosen as the primary study endpoint based upon data from an earlier CASG study finding that >3 cutaneous recurrences occurring in SEM infants within the first six months of life correlates with abnormal neurologic outcome when measured at 12 months of life. Suggesting that subclinical reactivation of HSV within the CNS may be occurring with this group of infants. Therefore, systematic study of suppressive acyclovir to prevent this presumed subclinical CNS reactivation and thus to improve neurologic outcome at 12 months of age is the primary goal of this investigation. This study will address the significance of a positive cerebrospinal fluid PCR result when all other CSF parameters remain normal. Comparisons will be made between groups with respect to time post-randomization to first positive cerebrospinal fluid PCR 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 SEM disease, and it will confirm the safety of long-term administration of oral acyclovir therapy in a cohort of infants with SEM disease. The effects of suppressive acyclovir therapy on issues of pharmacoeconomic and family infrastructure will be assessed and quantitated.