Herpes Simplex Clinical Trial
OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin
lesions and improves neurologic outcome in neonates with localized herpes simplex virus type
2 infection when administered for 6 months in a placebo-controlled study.
II. Determine whether the prevention of recurrent skin lesions reduces long-term neurologic
morbidity.
III. Determine whether resistant disease develops after oral ACV therapy. IV. Evaluate the
natural history of recurrent skin lesions. V. Measure any adverse effects and laboratory
abnormalities associated with long-term oral ACV therapy in infants and young children.
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
participating institution.
All patients are treated with intravenous acyclovir for 14 days. Patients are then randomly
assigned to 1 of 2 treatment groups if the following criteria are met: no systemic disease
involvement, documented by negative cerebrospinal fluid exam, brain computerized tomography,
and magnetic resonance imaging; and entry criteria continue to be met.
Randomized treatment begins 8 hours after the final dose of intravenous acyclovir. One group
is treated with oral acyclovir, while the control group receives an oral placebo.
Treatment continues for 6 months in the absence of unacceptable toxicity, systemic disease,
and 2 or more recurrences of skin lesions. Patients are followed at 6 months, then yearly
for at least 4 years.
The study duration is estimated to be 4 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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