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

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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). It will determine if suppressive oral acyclovir therapy improves neurologic outcome in infants following SEM disease (Primary Endpoint). 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. This suggests that subclinical reactivation of HSV within the central nervous system (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 also address the significance of a positive cerebrospinal fluid (CSF) 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 (Secondary Study Endpoint), 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 (Secondary Study Endpoint), and it will confirm the safety of long-term administration of oral acyclovir therapy in a cohort of infants with SEM disease (Tertiary Study Endpoint). Finally, the effects of suppressive acyclovir therapy on issues of pharmacoeconomic and family infrastructure will be assessed and quantitated.