Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
NCT ID: NCT00006135
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
66 participants
INTERVENTIONAL
1997-06-30
Brief Summary
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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.
Detailed Description
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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 arms.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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acyclovir
Eligibility Criteria
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Inclusion 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
0 Years
28 Days
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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David W. Kimberlin
Role: STUDY_CHAIR
University of Alabama at Birmingham
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
University of Arkansas
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital and Health Center
San Diego, California, United States
Stanford University
Stanford, California, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio State University Children's Hospital
Columbus, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Medical Center at Knoxville
Knoxville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas Southwestern Medical School
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
University of Manitoba-Winnipeg
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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UAB-CASG-104
Identifier Type: -
Identifier Source: secondary_id
199/15334
Identifier Type: -
Identifier Source: org_study_id