Herpes Simplex Clinical Trial
OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir
in infants with herpes simplex virus infection involving the central nervous system.
II. Determine whether neurologic outcome is improved in these patients when treated with
this regimen.
III. Determine whether continuous administration of this drug suppresses recurrent skin
lesions in these patients.
IV. Determine the safety of this regimen in these patients.
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients are stratified according to disease (CNS disease with or without cutaneous
involvement vs disseminated disease with CNS involvement).
All patients receive acyclovir IV every 8 hours on days 1-21. On day 19, patients undergo a
lumbar puncture and must have a negative CSF PCR to be randomized. If patients have a
positive CSF PCR on day 19, they continue to receive acyclovir IV every 8 hours. Treatment
continues every 7 days with a repeat CSF PCR on the fifth day until a negative CSF PCR
result is achieved. Patients are then randomized to one of two treatment arms.
Arm I: Patients receive oral acyclovir three times a day for 6 months. Arm II: Patients
receive placebo. In case of cutaneous recurrence during the first 12 months of the study,
patients receive open label oral acyclovir (if CSF PCR is negative) or acyclovir IV (if CSF
PCR is positive) for 5 days. Patients may or may not continue on study drug following this
treatment.
Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.
;
Primary Purpose: Treatment
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