Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
NCT ID: NCT00006132
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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UNKNOWN
PHASE3
132 participants
INTERVENTIONAL
1997-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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acyclovir
Eligibility Criteria
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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
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
Connecticut Children's Medical Center
Hartford, Connecticut, 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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Facility Contacts
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Richard J. Whitley
Role: primary
David W. Kimberlin
Role: primary
Richard Jacobs
Role: primary
Elias J. Anaissie
Role: primary
John Bradley
Role: primary
Ann Arvin
Role: primary
Alberto Cohen-Abbo
Role: primary
Rusell Van Dyke
Role: primary
Carol McCarthy
Role: primary
April Palmer
Role: primary
Gregory Storch
Role: primary
Leonard Weiner
Role: primary
Amina Ahmed
Role: primary
Lawrence Stanberry
Role: primary
Mary Lou Kumar
Role: primary
Dwight Powell
Role: primary
Penelope H. Dennehy
Role: primary
Sandra Fowler
Role: primary
Thomas Smith
Role: primary
Kathy Edwards
Role: primary
Pablo J. Sanchez
Role: primary
Mark Shelton
Role: primary
Gail Demmler
Role: primary
Charles Leach
Role: primary
Joan Robinson
Role: primary
Amin Kabani
Role: primary
Other Identifiers
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UAB-CASG-103
Identifier Type: -
Identifier Source: secondary_id
199/15325
Identifier Type: -
Identifier Source: org_study_id