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Phase 3
28 Days
Open (Enrolling)
Herpes Simplex

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Trial Information

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

Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.

Inclusion Criteria


--Disease Characteristics--

- Infants diagnosed with herpes simplex virus infection involving the central nervous
system with or without evidence of viral dissemination to other organs (i.e., skin,
liver, or lungs) HSV-1 or HSV-2 isolated from cutaneous lesions from any site (skin,
oropharynx, cerebrospinal fluid (CSF), urine, etc.) OR Must have positive CSF
polymerase chain reaction (PCR) if no cutaneous skin lesions are present and viral
cultures are negative No infection limited to skin, eyes, or mouth Evidence of CNS
involvement includes one or more of the following: Abnormal CSF indices for term
infants (WBC greater than 22/mm3 and protein greater than 115 mg/dL) Abnormal CSF
indices for preterm infants (WBC greater than 25/mm3 and protein greater than 220
mg/dL) Abnormal neuroimaging study (CT with contrast, MRI with gadolinium, or head
ultrasound) Disseminated disease is defined as one or more of the following: SGPT at
least 2.5 times upper limit of normal Pneumonia/pneumonitis Necrotizing enterocolitis
Disseminated intravascular coagulopathy

- 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

--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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David W. Kimberlin

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham


United States: Federal Government

Study ID:




Start Date:

June 1997

Completion Date:

Related Keywords:

  • Herpes Simplex
  • herpes simplex virus infection
  • herpes virus infection
  • immunologic disorders and infectious disorders
  • rare disease
  • viral infection
  • Herpes Simplex
  • Virus Diseases



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
Connecticut Children's Medical Center Hartford, Connecticut  06106
Vanderbilt University Nashville, Tennessee  37232-6305