Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006132
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-08-03
Brief Title:
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
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:
OBJECTIVES I Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection involving the central nervous system
II Determine whether neurologic outcome is improved in these patients when treated with this regimen
III Determine whether continuous administration of this drug suppresses recurrent skin lesions in these patients
IV Determine the safety of this regimen in these patients
II Determine whether neurologic outcome is improved in these patients when treated with this regimen
III Determine whether continuous administration of this drug suppresses recurrent skin lesions in these patients
IV Determine the safety of this regimen in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to disease CNS disease with or without cutaneous involvement vs disseminated disease with CNS involvement
All patients receive acyclovir IV every 8 hours on days 1-21 On day 19 patients undergo a lumbar puncture and must have a negative CSF PCR to be randomized If patients have a positive CSF PCR on day 19 they continue to receive acyclovir IV every 8 hours Treatment continues every 7 days with a repeat CSF PCR on the fifth day until a negative CSF PCR result is achieved Patients are then randomized to one of two treatment arms
Arm I Patients receive oral acyclovir three times a day for 6 months Arm II Patients receive placebo In case of cutaneous recurrence during the first 12 months of the study patients receive open label oral acyclovir if CSF PCR is negative or acyclovir IV if CSF PCR is positive for 5 days Patients may or may not continue on study drug following this treatment
Patients are followed at 6 12 24 36 48 and 60 months of age
All patients receive acyclovir IV every 8 hours on days 1-21 On day 19 patients undergo a lumbar puncture and must have a negative CSF PCR to be randomized If patients have a positive CSF PCR on day 19 they continue to receive acyclovir IV every 8 hours Treatment continues every 7 days with a repeat CSF PCR on the fifth day until a negative CSF PCR result is achieved Patients are then randomized to one of two treatment arms
Arm I Patients receive oral acyclovir three times a day for 6 months Arm II Patients receive placebo In case of cutaneous recurrence during the first 12 months of the study patients receive open label oral acyclovir if CSF PCR is negative or acyclovir IV if CSF PCR is positive for 5 days Patients may or may not continue on study drug following this treatment
Patients are followed at 6 12 24 36 48 and 60 months of age
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB-CASG-103 | None | None | None |