This is a randomized, double blind, placebo controlled, multicenter study.
All patients undergo a lumbar puncture and then receive acyclovir IV every 8 hours on Days
1-14. On Day 12, patients may undergo a lumbar puncture (at discretion of investigator).
Whole blood is obtained for herpes simplex virus PCR analysis. Upon completion of
intravenous therapy, patients with a negative CSF PCR are randomized to one of two treatment
Arm I: Patients receive oral acyclovir three times daily for 6 months.
Arm II: Patients receive placebo three times daily for 6 months.
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
David W. Kimberlin
University of Alabama at Birmingham
United States: Federal Government
|Baylor College of Medicine||Houston, Texas 77030|
|University of Alabama Comprehensive Cancer Center||Birmingham, Alabama 35294|
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|Rhode Island Hospital||Providence, Rhode Island 02903|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|State University of New York - Upstate Medical University||Syracuse, New York 13210|
|Stanford University||Stanford, California 94305|
|Maine Medical Center||Portland, Maine 04102|
|Cedars-Sinai Medical Center||Los Angeles, California 90048|
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Children's Hospital Medical Center - Cincinnati||Cincinnati, Ohio 45229-3039|
|Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Cook Children's Medical Center - Fort Worth||Fort Worth, Texas 76104|
|St. Louis Children's Hospital||Saint Louis, Missouri 63110|
|University of Texas Southwestern Medical School||Dallas, Texas 75235-9032|
|Children's Hospital and Health Center||San Diego, California 92123-4282|
|MetroHealth Medical Center||Cleveland, Ohio 44109|
|University of Tennessee Medical Center at Knoxville||Knoxville, Tennessee 37920|
|University of Florida Health Science Center - Jacksonville||Jacksonville, Florida 32209|
|Tulane University Medical Center||New Orleans, Louisiana 70112|
|Ohio State University Children's Hospital||Columbus, Ohio 43205-2696|
|Children's Hospital of Alabama||Birmingham, Alabama 35233|
|University of Arkansas||Little Rock, Arkansas 72202|
|Vanderbilt University||Nashville, Tennessee 37232-6305|