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Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth

Information source: National Center for Research Resources (NCRR)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Simplex

Intervention: acyclovir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Center for Research Resources (NCRR)

Official(s) and/or principal investigator(s):
David W. Kimberlin, Study Chair, Affiliation: University of Alabama at Birmingham


OBJECTIVES: 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.

Clinical Details

Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Detailed description: PROTOCOL OUTLINE: 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.


Minimum age: N/A. Maximum age: 28 Days. Gender(s): Both.



- -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

Locations and Contacts

Children's Hospital of Alabama, Birmingham, Alabama 35233, United States

University of Alabama Comprehensive Cancer Center, Birmingham, Alabama 35294, United States

University of Alberta, Edmonton, Alberta T6G 2R7, Canada

University of Arkansas, Little Rock, Arkansas 72202, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

Children's Hospital and Health Center, San Diego, California 92123-4282, United States

Stanford University, Stanford, California 94305, United States

University of Florida Health Science Center - Jacksonville, Jacksonville, Florida 32209, United States

Tulane University Medical Center, New Orleans, Louisiana 70112, United States

Maine Medical Center, Portland, Maine 04102, United States

University of Manitoba-Winnipeg, Winnipeg, Manitoba R3A 1R9, Canada

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

St. Louis Children's Hospital, Saint Louis, Missouri 63110, United States

State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio 45229-3039, United States

MetroHealth Medical Center, Cleveland, Ohio 44109, United States

Ohio State University Children's Hospital, Columbus, Ohio 43205-2696, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Medical University of South Carolina, Charleston, South Carolina 29425-0721, United States

University of Tennessee Medical Center at Knoxville, Knoxville, Tennessee 37920, United States

Vanderbilt University, Nashville, Tennessee 37232-6305, United States

University of Texas Southwestern Medical School, Dallas, Texas 75235-9032, United States

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States

Additional Information

Starting date: June 1997
Last updated: June 23, 2005

Page last updated: August 23, 2015

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