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

Completed · Phase 3

Conditions studied: Herpes Simplex

In brief

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.

Key facts

Study ID

NCT00006135

Run by

National Center for Research Resources (NCRR)

People needed

66

Starts

1997-06-01

Last updated by the study team

2005-06-24

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

Where it is running

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

Full record on ClinicalTrials.gov

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