Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004757
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin Eyes and Mouth
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-01
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 whether acyclovir ACV oral suspension suppresses recurrent skin lesions and improves neurologic outcome in neonates with localized herpes simplex virus type 2 infection when administered for 6 months in a placebo-controlled study
II Determine whether the prevention of recurrent skin lesions reduces long-term neurologic morbidity
III Determine whether resistant disease develops after oral ACV therapy IV Evaluate the natural history of recurrent skin lesions V Measure any adverse effects and laboratory abnormalities associated with long-term oral ACV therapy in infants and young children
II Determine whether the prevention of recurrent skin lesions reduces long-term neurologic morbidity
III Determine whether resistant disease develops after oral ACV therapy IV Evaluate the natural history of recurrent skin lesions V Measure any adverse effects and laboratory abnormalities associated with long-term oral ACV therapy in infants and young children
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Patients are stratified by participating institution
All patients are treated with intravenous acyclovir for 14 days Patients are then randomly assigned to 1 of 2 treatment groups if the following criteria are met no systemic disease involvement documented by negative cerebrospinal fluid exam brain computerized tomography and magnetic resonance imaging and entry criteria continue to be met
Randomized treatment begins 8 hours after the final dose of intravenous acyclovir One group is treated with oral acyclovir while the control group receives an oral placebo
Treatment continues for 6 months in the absence of unacceptable toxicity systemic disease and 2 or more recurrences of skin lesions Patients are followed at 6 months then yearly for at least 4 years
The study duration is estimated to be 4 years
All patients are treated with intravenous acyclovir for 14 days Patients are then randomly assigned to 1 of 2 treatment groups if the following criteria are met no systemic disease involvement documented by negative cerebrospinal fluid exam brain computerized tomography and magnetic resonance imaging and entry criteria continue to be met
Randomized treatment begins 8 hours after the final dose of intravenous acyclovir One group is treated with oral acyclovir while the control group receives an oral placebo
Treatment continues for 6 months in the absence of unacceptable toxicity systemic disease and 2 or more recurrences of skin lesions Patients are followed at 6 months then yearly for at least 4 years
The study duration is estimated to be 4 years
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 |
|---|---|---|---|
| NIAID-558609 | None | None | None |