Herpes Simplex Clinical Trial
OBJECTIVES: I. Evaluate whether high-dose acyclovir decreases acute and long-term morbidity
and mortality in neonates with central nervous system or disseminated herpes simplex virus
(HSV) infection.
II. Evaluate whether high-dose acyclovir is safe and tolerated in the newborn. III. Assess
resistance to antiviral medication. IV. Amplify disease classification for the purpose of
predicting prognosis. V. Assess any changes in viral excretion patterns. VI. Evaluate
whether antigens and antibodies specific for HSV glycoproteins within the cerebrospinal
fluid (CSF) predict long-term neurologic outcome.
VII. Evaluate whether specific antigens and antibodies in the CSF appear late after
treatment and are indicative of insidious reactivation of virus in the brain.
PROTOCOL OUTLINE:
Neonates are treated with intravenous acyclovir for 21 days. Patients are followed at day
28, and at 6, 12, 24, 36, and 48 months.
;
Primary Purpose: Treatment
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