Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/2/2016
Start Date:June 1997

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OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir
in infants with herpes simplex virus infection involving the central nervous system.

II. Determine whether neurologic outcome is improved in these patients when treated with
this regimen.

III. Determine whether continuous administration of this drug suppresses recurrent skin
lesions in these patients.

IV. Determine the safety of this regimen in these patients.

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.

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
We found this trial at
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Saint Louis, Missouri 63110
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
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655 West 8th Street
Jacksonville, Florida 32209
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1924 Alcoa Highway
Knoxville, Tennessee 37920
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Little Rock, Arkansas 72202
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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San Diego, California 92123
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
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New Orleans, Louisiana 70112
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
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