Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006135
Status:
COMPLETED
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 Limited to Skin Eyes and Mouth
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
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:
OBJECTIVES
I Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin eyes and mouth
II Determine the neurologic outcome in these patients when treated with this regimen
III Evaluate the significance of a positive cerebrospinal fluid CSF polymerase chain reaction PCR result when all other CSF parameters remain normal in these patients
IV Correlate the time to first positive CSF PCR result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen
V Determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients
VI Determine the safety of this regimen in these patients
I Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin eyes and mouth
II Determine the neurologic outcome in these patients when treated with this regimen
III Evaluate the significance of a positive cerebrospinal fluid CSF polymerase chain reaction PCR result when all other CSF parameters remain normal in these patients
IV Correlate the time to first positive CSF PCR result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen
V Determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients
VI Determine the safety of this regimen in these patients
Detailed Description:
PROTOCOL OUTLINE
This is a randomized double blind placebo controlled multicenter study
All patients undergo a lumbar puncture and then receive acyclovir IV every 8 hours on Days 1-14 On Day 12 patients may undergo a lumbar puncture at discretion of investigator Whole blood is obtained for herpes simplex virus PCR analysis Upon completion of intravenous therapy patients with a negative CSF PCR are randomized to one of two treatment arms
Arm I Patients receive oral acyclovir three times daily for 6 months
Arm II Patients receive placebo three times daily for 6 months
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
This is a randomized double blind placebo controlled multicenter study
All patients undergo a lumbar puncture and then receive acyclovir IV every 8 hours on Days 1-14 On Day 12 patients may undergo a lumbar puncture at discretion of investigator Whole blood is obtained for herpes simplex virus PCR analysis Upon completion of intravenous therapy patients with a negative CSF PCR are randomized to one of two treatment arms
Arm I Patients receive oral acyclovir three times daily for 6 months
Arm II Patients receive placebo three times daily for 6 months
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-104 | None | None | None |