N/A
28 Days
Both
Herpes Simplex
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
treatment.
Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.
Inclusion Criteria
PROTOCOL ENTRY 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:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
David W. Kimberlin
Investigator Role:
Study Chair
Investigator Affiliation:
University of Alabama at Birmingham
Authority:
United States: Federal Government
Study ID:
199/15325
NCT ID:
NCT00006132
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
Name | Location |
|---|---|
| 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 |
