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NCT00031460 · ClinicalTrials.gov registry record · Phase 3
Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 46
- Enrollment target
NCT00031460 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 46 participants.
The verdict
NCT00031460, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 46 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Acyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 1997-12 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00031460
The ClinicalTrials.gov registry entry for NCT00031460 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00031460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00031460 about?
NCT00031460 is a clinical study titled "Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates". 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 ...
What is the current status of trial NCT00031460?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 46 participants. The study started on 1997-12. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00031460?
The interventions under investigation include: Placebo (DRUG), Acyclovir (DRUG).
Who is sponsoring clinical trial NCT00031460?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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