HIGH DOSE ACYCLOVIR VERSUS VIDARABINE IN NEONATAL HERPES SIMPLEX INFECTION

我们假设用大剂量阿昔洛韦治疗可以减少 CNS或播散性新生儿单纯疱疹的死亡率和发病率 急性和长期的病毒感染。 这项试验是随机的， 双盲对照临床试验，使用高剂量阿昔洛韦与 标准阿糖腺苷治疗。患者将在GCRC接受治疗， 连续21天，然后从第28天至第6天间歇给药 个月 将进行实验室工作，包括脑脊液脊髓穿刺 在第1天和第21天。 将在第1天和第21天进行CT，其他CT为 有医学指征。 随访门诊访视将在1、2、3和 4年，将包括神经和发育评估。 在研究的第一阶段，全国范围内的16名婴儿被招募 剂量为45 mg/kg/天。 在此期间没有毒性证据 剂量;因此，药物剂量递增至60 mg/kg/天。 共 在所有研究中心，72例患者以60 mg/kg/天剂量入组。 今年UAB未入组新患者; 3次门诊访视 记录以进行随访。

We hypothesized that treatment with high dose acyclovir would decrease mortality and morbidity of CNS or disseminated neonatal herpes simplex virus infection both acutely and long-term. This trial is a randomized, double-blind controlled clinical trial utilizing high dose acyclovir Vs. standard vidarabine therapy. Patients will be treated in the GCRC for twenty-one consecutive days and then intermittently from day 28 through 6 months. Laboratory work including spinal tap for CSF fluid will be done on days 1 and 21. CT will be done on days 1 and 21 with other CTs as medically indicated. Follow-up out-patient visits will be at 1, 2, 3 and 4 years and will include neurological and developmental assessments. During the first phase of the study, 16 babies nation-wide were enrolled at a dosage of 45mg/kg/day. There was no evidence of toxicity at this doseage; thus, medication doseage was escalated to 60mg/kg/day. A total of 72 patients have been enrolled at the 60mg/kg/day dose at all centers. No new patients have been enrolled at UAB this year; 3 outptaient visits were recorded for follow-up.