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NCT00031447 · ClinicalTrials.gov registry record · Phase 3
Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 29
- Enrollment target
NCT00031447: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00031447 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 29 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00031447, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 29 participants
- Enrollment target
Study Summary
The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes, and mouth (SEM). Study participants will include infants in the United States and Canada who have HSV disease of the skin, eyes, and mouth, with no central nervous system disease present. Initially, all subjects will be treated with acyclovir administered through IV access (through the vein) for 14 days while hospitalized. Participants will then be placed in one of two groups, acyclovir given by mouth or a placebo (substance with no medication present). The participant and the study site will not know to which group the subject is assigned. All children will be followed at 6, 12, 24, 36, 48, and 60 months of age. During the follow up visits, physicals, hearing assessments, eye assessments, and neurological assessments will be completed.
Primary Outcome
Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development and less than or equal to 69 suggests significant delayed development.
Interventions
- DRUG Placebo
- DRUG Acyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 1999-08 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
What the finished NCT00031447 record still lists
NCT00031447 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00031447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00031447 about?
NCT00031447 is a clinical study titled "Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth". The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes, and mouth (SEM). Study participants will include infants in the United States and Canada who have HSV disease of the skin, ...
What is the current status of trial NCT00031447?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 29 participants. The study started on 1999-08. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00031447?
The interventions under investigation include: Placebo (DRUG), Acyclovir (DRUG).
Who is sponsoring clinical trial NCT00031447?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00031447's enrollment target sits among peer trials
29 1933rd of 2000 higher than 66 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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