Herpes Simplex
Conditions
Keywords
herpes simplex virus infection, herpesvirus infection, immunologic disorders and infectious disorders, rare disease, viral infection
Brief summary
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.
Detailed description
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.
Interventions
DRUGacyclovir
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
National Center for Research Resources (NCRR)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
0 Years to 28 Days
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Herpes simplex virus infection that is disseminated or localized to the central nervous system Virologically confirmed by 1 of the following methods: * Tissue culture * Monoclonal antibody staining * Electron microscopy --Prior/Concurrent Therapy-- No concurrent antiviral therapy --Patient Characteristics-- Life expectancy: No imminent demise Birth weight at least 1200 g Gestational age over 32 weeks
Outcome results
None listed