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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: Completed Phase 3 study, sponsored by National Center for Research Resources (NCRR).

NCT00006135 is a Phase 3 study that has completed, run by National Center for Research Resources (NCRR). The registered enrollment target is 66 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 66 participants
Start Date 1997-06
Phase Phase 3

What the finished NCT00006135 record still lists

NCT00006135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 1 intervention - of which acyclovir is the first listed.

NCT00006135 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00006135's enrollment target sits among peer trials

66 1797th of 2000 higher than 204 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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Source: ClinicalTrials.gov NCT00006135, the US trial registry maintained by the National Library of Medicine. NCT00006135 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.