Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-27 @ 2:35 PM
Study NCT ID:
NCT00004757
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NIAID-558609 | None | None | View |