Document Detail

Administration of oral acyclovir suppressive therapy after neonatal herpes simplex virus disease limited to the skin, eyes and mouth: results of a phase I/II trial.
MedLine Citation:
PMID:  8852914     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Neonatal herpes simplex virus (HSV) infections limited to the skin, eyes and mouth (SEM) can result in neurologic impairment. A direct correlation exists between the development of neurologic deficits and the frequency of cutaneous HSV recurrences. Thus, the National Institutes of Allergy and Infectious Diseases Collaborative Antiviral Study Group conducted a Phase I/II trial of oral acyclovir therapy for the suppression of cutaneous recurrences after SEM disease in 26 neonates. METHODS: Infants < or = 1 month of age with virologically confirmed HSV-2 SEM disease were eligible for enrollment. Suppressive oral acyclovir therapy (300 mg/m2/dose given either twice daily or three times per day) was administered for 6 months. RESULTS: Twelve (46%) of the 26 infants developed neutropenia (< 1000 cells/mm3) while receiving acyclovir. Thirteen (81%) of the 16 infants who received drug 3 times per day experienced no recurrences of skin lesions while receiving therapy. In comparison, a previous Collaborative Antiviral Study Group study found that only 54% of infants have no cutaneous recurrences in the 6 months after resolution of neonatal HSV disease if oral acyclovir suppressive therapy is not initiated. In one infant, HSV DNA was detected in the cerebrospinal fluid during a cutaneous recurrence, and an acyclovir-resistant HSV mutant was isolated from another patient during the course of the study. CONCLUSIONS: Administration of oral acyclovir can prevent cutaneous recurrences of HSV after neonatal SEM disease. The effect of such therapy on neurologic outcome must be assessed in a larger, Phase III study. As such, additional investigation is necessary before routine use of suppressive therapy in this population can be recommended.
D Kimberlin; D Powell; W Gruber; P Diaz; A Arvin; M Kumar; R Jacobs; R Van Dyke; S Burchett; S J Soong; A Lakeman; R Whitley
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  The Pediatric infectious disease journal     Volume:  15     ISSN:  0891-3668     ISO Abbreviation:  Pediatr. Infect. Dis. J.     Publication Date:  1996 Mar 
Date Detail:
Created Date:  1996-12-05     Completed Date:  1996-12-05     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  8701858     Medline TA:  Pediatr Infect Dis J     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  247-54     Citation Subset:  IM    
Department of Pediatrics, University of Alabama at Birmingham 35233, USA.
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MeSH Terms
Acyclovir / pharmacokinetics,  therapeutic use*
Administration, Oral
Antiviral Agents / pharmacokinetics,  therapeutic use*
Drug Resistance
Eye Infections, Viral / cerebrospinal fluid,  drug therapy*,  virology
Herpes Genitalis / cerebrospinal fluid,  drug therapy*,  virology
Herpesvirus 2, Human / drug effects*,  genetics
Infant, Newborn
Mouth Diseases / cerebrospinal fluid,  drug therapy*,  virology
Retrospective Studies
Skin Diseases, Viral / cerebrospinal fluid,  drug therapy*,  virology
Grant Support
Reg. No./Substance:
0/Antiviral Agents; 59277-89-3/Acyclovir

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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