Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031447
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2002-03-06
Brief Title:
Acyclovir Herpes Simplex Virus HSV Skin Eye and Mouth
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Placebo-Controlled Phase III Evaluation of Suppressive Therapy With Oral Acyclovir Suspension Following Neonatal Herpes Simplex Virus Infections Limited to the Skin Eye and Mouth
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Neonatal herpes simplex virus HSV disease complicates approximately one in every 3000 births in the United States This study will be a placebo-controlled Phase III evaluation of suppressive therapy with oral Acyclovir suspension following neonatal HSV infections limited to the skin eyes and mouth SEM This study will evaluate the efficacy of long-term suppressive therapy with oral acyclovir in infants with SEM disease It will determine if suppressive oral acyclovir therapy improves neurological outcome in infants following SEM disease Only infants with SEM disease will qualify for this study After qualifying for the study and obtaining informed consent the infant will complete 14 days of intravenous IV Acyclovir 20 mgkgdose given every 8 hours Patients will be randomized to receive suppressive oral Acyclovir versus placebo only if they continue to meet all study inclusion criteria at the completion of the IV therapy This study will be double-blinded and placebo controlled At the time of randomization the patient will be placed in 1 of 2 groups oral suppressive Acyclovir versus placebo If a patient in either group has a cutaneous HSV recurrence open-label oral Acyclovir 80 mgkgday divided into 4 doses per day will be provided for 5 days During the time of administration of open-label oral Acyclovir study drug will be withheld All children will be followed at 6 12 24 36 48 and 60 months of age Physical examination hearing assessment and retinal examination will be performed at each follow up visit Standardized neurologic evaluation will be performed at 12 24 36 48 and 60 months of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01AI30025C | None | None | None |
| CASG 104 | None | None | None |