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

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R7
        • Recruiting
        • University of Alberta
        • Contact:
          • Joan Robinson
          • Phone Number: 780-492-1680
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Recruiting
        • University of Manitoba-Winnipeg
        • Contact:
          • Amin Kabani
          • Phone Number: 204-787-1928
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's Hospital of Alabama
        • Contact:
          • Richard J. Whitley
          • Phone Number: 205-934-5316
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Comprehensive Cancer Center
        • Contact:
          • David W. Kimberlin
          • Phone Number: 205-939-6097
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
          • Elias J. Anaissie
          • Phone Number: 501-686-8274
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • University of Arkansas
        • Contact:
          • Richard Jacobs
          • Phone Number: 501-320-1416
    • California
      • Los Angeles, California, United States, 90048
        • Completed
        • Cedars-Sinai Medical Center
      • San Diego, California, United States, 92123-4282
        • Recruiting
        • Children's Hospital and Health Center
        • Contact:
          • John Bradley
          • Phone Number: 619-576-5823
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
          • Ann Arvin
          • Phone Number: 650-723-5682
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Connecticut Children's Medical Center
        • Contact:
          • Alberto Cohen-Abbo
          • Phone Number: 860-545-9330
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Active, not recruiting
        • University of Florida Health Science Center - Jacksonville
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University Medical Center
        • Contact:
          • Rusell Van Dyke
          • Phone Number: 504-588-5422
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center
        • Contact:
          • Carol McCarthy
          • Phone Number: 207-828-8226
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
          • April Palmer
          • Phone Number: 601-984-5206
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis Children's Hospital
        • Contact:
          • Gregory Storch
          • Phone Number: 314-454-6079
    • New York
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York - Upstate Medical University
        • Contact:
          • Leonard Weiner
          • Phone Number: 315-464-6331
    • North Carolina
      • Charlotte, North Carolina, United States, 28232-2861
        • Recruiting
        • Carolinas Medical Center
        • Contact:
          • Amina Ahmed
          • Phone Number: 704-355-1301
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Recruiting
        • Children's Hospital Medical Center - Cincinnati
        • Contact:
          • Lawrence Stanberry
          • Phone Number: 513-559-6773
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center
        • Contact:
          • Mary Lou Kumar
          • Phone Number: 216-778-4284
      • Columbus, Ohio, United States, 43205-2696
        • Recruiting
        • Ohio State University Children's Hospital
        • Contact:
          • Dwight Powell
          • Phone Number: 614-722-4450
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
          • Penelope H. Dennehy
          • Phone Number: 401-444-4298
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0721
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Sandra Fowler
          • Phone Number: 843-792-2385
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center at Knoxville
        • Contact:
          • Thomas Smith
          • Phone Number: 423-544-9356
      • Nashville, Tennessee, United States, 37232-6305
        • Recruiting
        • Vanderbilt University
        • Contact:
          • Kathy Edwards
          • Phone Number: 615-322-2250
    • Texas
      • Dallas, Texas, United States, 75235-9032
        • Recruiting
        • University of Texas Southwestern Medical School
        • Contact:
          • Pablo J. Sanchez
          • Phone Number: 214-648-3753
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Cook Children's Medical Center - Fort Worth
        • Contact:
          • Mark Shelton
          • Phone Number: 817-885-4000
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
          • Gail Demmler
          • Phone Number: 713-770-4330
      • San Antonio, Texas, United States, 78284-7811
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
          • Charles Leach
          • Phone Number: 210-567-5246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Alabama at Birmingham

Investigators

  • Study Chair: David W. Kimberlin, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1997

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

August 3, 2000

First Posted (Estimate)

August 4, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/15325
  • UAB-CASG-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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