OBJECTIVES:
I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants
with herpes simplex virus infection limited to skin, eyes, and mouth.
II. Determine the neurologic outcome in these patients when treated with this regimen.
III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain
reaction (PCR) result when all other CSF parameters remain normal in these patients.
IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with
clinical neurological assessment in these patients when treated with this regimen.
V. Determine whether the continuous administration of this drug suppresses recurrent skin
lesions in these patients.
VI. Determine the safety of this regimen in these patients.
Minimum age: N/A.
Maximum age: 28 Days.
Gender(s): Both.
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics--
Infants diagnosed with herpes simplex virus infection limited to skin, eyes, and mouth;
HSV-1 or HSV-2 isolated from cutaneous lesions, conjunctivae, or oropharynx (presence of
skin lesions not required); normal CSF indices: WBC less than 22/mm3 and protein less than
115 mg/dL for term infants OR WBC less than 25/mm3 and protein less than 220 mg/dL for
preterm infants; no evidence of CNS involvement by CT with contrast, MRI with gadolinium,
or head ultrasound; no visceral dissemination (normal liver function tests, normal chest
x-ray, etc.); negative CSF PCR result
Birth weight at least 800 grams
- -Prior/Concurrent Therapy--
No concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or
famciclovir for longer than 120 hours or 5 days; no prior prophylactic acyclovir for risk
of herpes simplex virus infection
- -Patient Characteristics--
Renal: Creatinine no greater than 1. 5 mg/dL
Cardiovascular: No prior grade 3 or 4 intraventricular hemorrhage
Other: No infants known to be born to HIV-positive women
Children's Hospital of Alabama, Birmingham, Alabama 35233, United States
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama 35294, United States
University of Alberta, Edmonton, Alberta T6G 2R7, Canada
University of Arkansas, Little Rock, Arkansas 72202, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Cedars-Sinai Medical Center, Los Angeles, California 90048, United States
Children's Hospital and Health Center, San Diego, California 92123-4282, United States
Stanford University, Stanford, California 94305, United States
University of Florida Health Science Center - Jacksonville, Jacksonville, Florida 32209, United States
Tulane University Medical Center, New Orleans, Louisiana 70112, United States
Maine Medical Center, Portland, Maine 04102, United States
University of Manitoba-Winnipeg, Winnipeg, Manitoba R3A 1R9, Canada
University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States
St. Louis Children's Hospital, Saint Louis, Missouri 63110, United States
State University of New York - Upstate Medical University, Syracuse, New York 13210, United States
Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio 45229-3039, United States
MetroHealth Medical Center, Cleveland, Ohio 44109, United States
Ohio State University Children's Hospital, Columbus, Ohio 43205-2696, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Medical University of South Carolina, Charleston, South Carolina 29425-0721, United States
University of Tennessee Medical Center at Knoxville, Knoxville, Tennessee 37920, United States
Vanderbilt University, Nashville, Tennessee 37232-6305, United States
University of Texas Southwestern Medical School, Dallas, Texas 75235-9032, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States
Baylor College of Medicine, Houston, Texas 77030, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States