Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
- Conditions
- Herpes Simplex
- Registration Number
- NCT00006135
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
University of Texas Southwestern Medical School
🇺🇸Dallas, Texas, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Ohio State University Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Florida Health Science Center - Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Manitoba-Winnipeg
🇨🇦Winnipeg, Manitoba, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Children's Hospital and Health Center
🇺🇸San Diego, California, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
University of Tennessee Medical Center at Knoxville
🇺🇸Knoxville, Tennessee, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Stanford University
🇺🇸Stanford, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States