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

Herpes Simplex Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00006132
• Other study ID #: 199/15325
• Secondary ID: UAB-CASG-103
• Status: Recruiting
• Phase: Phase 3
• First received: August 3, 2000
• Last updated: June 23, 2005
• Start date: June 1997

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Drug:
• acyclovir

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	University of Manitoba-Winnipeg	Winnipeg	Manitoba
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
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	University of Texas Southwestern Medical School	Dallas	Texas
United States	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Florida Health Science Center - Jacksonville	Jacksonville	Florida
United States	University of Tennessee Medical Center at Knoxville	Knoxville	Tennessee
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	Vanderbilt University	Nashville	Tennessee
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	Maine Medical Center	Portland	Maine
United States	Rhode Island Hospital	Providence	Rhode Island
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Children's Hospital and Health Center	San Diego	California
United States	Stanford University	Stanford	California
United States	State University of New York - Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of Alabama at Birmingham

Countries where clinical trial is conducted

United States,  Canada,