Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031460
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2002-03-06
Brief Title:
Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates
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 Involving the Central Nervous System
Status:
COMPLETED
Status Verified Date:
2009-10
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 acyclovir given orally by mouth improves the outcome for infants with herpes simplex virus infection of the brain or spinal cord known as the central nervous system CNS Infants with herpes viral infection of the CNS that has or has not spread to other parts of the body will be enrolled in this study All participants will receive treatment in a hospital for 21 days with acyclovir given intravenously by a needle inserted into a vein Participants will then be divided into two groups those with CNS disease that has or has not spread to the skin and those whose viral infection has spread and involves the CNS Both groups will be randomly assigned to receive either oral acyclovir or placebo inactive substance for 6 months Infants in the US and Canada will participate for 5 years A physical exam hearing exam eye exam and an evaluation of the nervous system will be performed throughout the study
Detailed Description:
Neonatal herpes simplex virus HSV disease complicates approximately 1 in every 3000 deliveries in the United States resulting in an estimated 1 500 cases annually in this country HSV-1 and HSV-2 infections in the neonate can manifest as disseminated disease central nervous system CNS disease or disease limited to the skin eyes and mouth SEM disease This study will evaluate the efficacy of long term suppressive therapy with oral acyclovir in infants with CNS disease with or without evidence of dissemination to other organs including the skin It will determine if suppressive oral acyclovir therapy improves neurologic outcome in infants following HSV disease with CNS involvement and address the significance of a positive cerebral spinal fluid CSF polymerase chain reaction PCR result when all other CSF parameters either remain normal or show improvement Comparisons will be made between groups with respect to post-randomization time to first positive CSF PCR result during the initial 12 months of life and results will be correlated with clinical neurological assessments It will determine if continuous administration of oral acyclovir suspension suppresses recurrent skin lesions in infants following HSV disease with CNS involvement and it will confirm the safety of long-term administration of oral acyclovir therapy in a cohort of infants with HSV disease with CNS involvement Finally the effects of suppressive acyclovir therapy on issues of pharmacoeconomics and family infrastructure will be assessed and quantitated Infants with CNS disease with or without evidence of viral dissemination to other organs such as the skin liver and lungs will qualify for this study Following a 21 day course of treatment with intravenous IV acyclovir infants with CNS disease with or without cutaneous involvement will be randomized to either continuous oral acyclovir or placebo CNS Sub-Study Similarly infants with disseminated disease with CNS involvement will be randomized to either continuous oral acyclovir or placebo Disseminated with CNS Involvement Sub-Study The subset of infants with CNS disease with or without dissemination who do not clear their acute infection in 21 days of IV acyclovir therapy will be eligible for enrollment in a Pilot Sub-Study This group is expected to be of insufficient number to be able to obtain statistical significance for establishing efficacy Per protocol amendment dated 19-Nov-1998 66 subjects will be recruited into each sub-study Subjects will begin oral drug therapy 8 hours after the final IV acyclovir dose and oral drug therapy will be administered for 6 months Whole blood 10 cubic centimeter will be obtained at study enrollment and at completion of IV antiviral therapy for HSV PCR analysis per protocol amendment dated 4-May-1998 This amendment replaces the obtaining of serum for HSV PCR analysis In the event that whole blood is not available serum will be provided instead 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 neurological evaluations will be performed at 12 24 36 48 and 60 months The primary study endpoint will evaluate neurological impairment at 12 months of life The secondary endpoints will evaluate post-randomization detection of HSV DNA in CSF by PCR at any time during the initial 12 months of life and 2 or fewer episodes post-randomization of cutaneous recurrence of HSV disease during the initial 12 months of life
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 103 | None | None | None |