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NCT00006135 · ClinicalTrials.gov registry record · Phase 3
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
A Phase 3 study, sponsored by National Center for Research Resources (NCRR).
- Completed
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
NCT00006135 is a Phase 3 study that has completed, run by National Center for Research Resources (NCRR). The registered enrollment target is 66 participants.
The verdict
NCT00006135, a Phase 3 study, has completed, sponsored by National Center for Research Resources (NCRR).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
Study 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.
Interventions
- DRUG acyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 1997-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006135
The ClinicalTrials.gov registry entry for NCT00006135 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which acyclovir is the first listed.
NCT00006135 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006135 about?
NCT00006135 is a clinical study titled "Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth". 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 po...
What is the current status of trial NCT00006135?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 1997-06.
What interventions are being tested in trial NCT00006135?
The interventions under investigation include: acyclovir (DRUG).
Who is sponsoring clinical trial NCT00006135?
This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.
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