Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)