Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
- Conditions
- Herpes Simplex
- Registration Number
- NCT00006132
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 132
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 (28)
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
University of Texas Southwestern Medical School
🇺🇸Dallas, Texas, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Ohio State University Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Manitoba-Winnipeg
🇨🇦Winnipeg, Manitoba, Canada
Children's Hospital and Health Center
🇺🇸San Diego, California, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, 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
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
University of Tennessee Medical Center at Knoxville
🇺🇸Knoxville, Tennessee, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States