Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth

Completed · Phase 3 · Has a placebo group

Conditions studied: Herpes Simplex

In brief

The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes, and mouth (SEM). Study participants will include infants in the United States and Canada who have HSV disease of the skin, eyes, and mouth, with no central nervous system disease present. Initially, all subjects will be treated with acyclovir administered through IV access (through the vein) for 14 days while hospitalized. Participants will then be placed in one of two groups, acyclovir given by mouth or a placebo (substance with no medication present). The participant and the study site will not know to which group the subject is assigned. All children will be followed at 6, 12, 24, 36, 48, and 60 months of age. During the follow up visits, physicals, hearing assessments, eye assessments, and neurological assessments will be completed.

Key facts

Study ID

NCT00031447

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

29

Starts

1999-08-01

Expected to finish

2008-04-01

Last updated by the study team

2012-05-16

Who can join

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

You may qualify if…

• Isolation by viral culture of herpes simplex virus (HSV)-1or HSV-2 from cutaneous lesions, conjunctivae, or oropharynx. Detection of HSV at any of these sites is sufficient, and the presence of skin lesions is not required for study enrollment.
• Normal cerebrospinal fluid (CSF) indices (<22 white blood cells (WBCs)/mm\^3 and protein <115 mg/dl for term infants; (<25 WBCs/mm\^3 and protein <220 mg/dl for preterm infants both at the time of diagnosis of HSV disease and at the time of study randomization.
• No evidence of HSV central nervous system (CNS) disease by computed tomography (CT) with contrast, magnetic resonance imaging (MRI) with gadolinium, or head ultrasound (HUS) [NOTE: CT with contrast is the preferred imaging study].
• Normal electroencephalogram (EEG), if performed [NOTE: EEG is suggested for the evaluation of infants with HSV disease but is not required for this study].
• No evidence of visceral dissemination of HSV infection (normal liver function tests, normal chest x-ray, etc.).
• Negative CSF HSV polymerase chain reaction (PCR) results from specimens obtained both within 72 hours of initiation of intravenous acyclovir therapy and within 48 hours prior to completion of intravenous acyclovir therapy.
• Less than or equal to 28 days of age at the time of initial presentation with skin, eyes, and mouth (SEM) disease.
• Birth weight greater than or equal to equal to 800 grams.

You may not qualify if…

• Infants with either grade 3 or grade 4 intraventricular hemorrhage (IVH) prior to study enrollment.
• Breast feeding infants whose mothers are taking acyclovir, valacyclovir, or famciclovir for >120 hours (>5 days). If at any point following enrollment the mother takes these antiviral drugs for >120 hours (>5 days), she will be asked to refrain from breast feeding while taking the drug.
• Infants known to be born to women who are human immunodeficiency virus (HIV) positive (but HIV testing is not required for study entry). These infants are at known risk for acquiring HIV, which would alter their immune response to other infections, including HSV infection. Additionally, they may be receiving antiretroviral and/or antiviral drugs during the time in which the study of suppressive oral acyclovir is being conducted. As such, they will be excluded if the mother's positive HIV status is known at the time of evaluation for study inclusion. If at any point following enrollment it is learned that an infant is HIV positive, he/she will be continued on the study protocol.
• Infants with either central nervous system (CNS) or disseminated HSV infection. Patients with CNS HSV infection will be considered for enrollment and randomization in the ongoing Collaborative Antiviral Study Group (CASG) evaluation of oral suppressive acyclovir therapy following neonatal HSV infections involving the CNS.
• Infants with creatinine >1.5mg/dl at time of study enrollment.
• Infants receiving acyclovir expectantly do not qualify for this study because they never developed HSV disease. Expectant therapy describes infants who are cultured at approximately 24 hours of life because of a risk of HSV infection (i.e. they are born to women with active genital lesions). Oftentimes, if these cultures are positive, the infant will receive a course of intravenous acyclovir to prevent the development of HSV disease. However, since they never actually had HSV disease, their potential outcome cannot be compared with infants with typical skin, eyes, and mouth (SEM) disease, and so they are not included in this study.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arkansas Children's Hospital, Department of Infectious Diseases — Little Rock, Arkansas, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• University of Florida - College of Medicine - Jacksonville — Jacksonville, Florida, United States
• The University of Chicago - Comer Children's Hospital - Infectious Diseases — Chicago, Illinois, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Tulane University - Tulane Medical Center - Department of Pediatrics — New Orleans, Louisiana, United States
• Maine Medical Center - Department of Pediatric Specialty Care - Infectious Disease — Portland, Maine, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Children's Hospital of Michigan - Pediatric Infectious Diseases — Detroit, Michigan, United States
• University of Mississippi — Jackson, Mississippi, United States
• Washington University School of Medicine in St. Louis - Center for Clinical Studies — St Louis, Missouri, United States
• Mount Sinai Hospital — New York, New York, United States
• UNY Upstate Medical University Hospital - Pediatrics — Syracuse, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• MetroHealth Medical Center - Pediatric Infectious Disease — Cleveland, Ohio, United States
• Nationwide Children's Hospital - Infectious Diseases — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Cook Children's Infectious Disease Services — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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