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Antiviral

Oral Acyclovir for Herpes

Phase 3
Waitlist Available
Research Sponsored by National Center for Research Resources (NCRR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants diagnosed with herpes simplex virus infection involving the central nervous system with or without evidence of viral dissemination to other organs
HSV-1 or HSV-2 isolated from cutaneous lesions from any site OR must have positive CSF polymerase chain reaction (PCR) if no cutaneous skin lesions are present and viral cultures are negative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing whether long-term suppressive therapy with oral acyclovir improves outcomes in infants with herpes simplex virus infection involving the central nervous system.

Who is the study for?
This trial is for infants with herpes simplex virus infection affecting the brain. They must have abnormal CSF or neuroimaging, weigh at least 800 grams, and not be born to HIV positive mothers. Infants can't join if they have high creatinine levels, severe brain hemorrhage history, or are breastfed by mothers on certain antiviral meds for over 5 days.Check my eligibility
What is being tested?
The study tests long-term oral acyclovir's effectiveness in treating infants' herpes infections of the central nervous system. It aims to see if this treatment improves neurological outcomes and prevents skin lesion recurrences while assessing its safety.See study design
What are the potential side effects?
While specific side effects aren't listed here, oral acyclovir generally may cause nausea, diarrhea, headache, vomiting and potential kidney issues in some patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My infant has a herpes infection in the brain, possibly affecting other organs.
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I have tested positive for herpes (HSV-1 or HSV-2) from a skin lesion or through a CSF PCR test.
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I do not have infections in my skin, eyes, or mouth.
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My brain or spinal cord is affected by my condition.
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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Find a Location

Who is running the clinical trial?

National Center for Research Resources (NCRR)Lead Sponsor
537 Previous Clinical Trials
316,884 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,581 Previous Clinical Trials
2,277,897 Total Patients Enrolled
David W. KimberlinStudy ChairUniversity of Alabama at Birmingham
1 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

Acyclovir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT00006132 — Phase 3
Herpes Research Study Groups:
Herpes Clinical Trial 2023: Acyclovir Highlights & Side Effects. Trial Name: NCT00006132 — Phase 3
Acyclovir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00006132 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this treatment have any harmful side effects?

"The safety of this treatment was rated a 3 by our team at Power. This is because it has reached Phase 3 in clinical trials, meaning that there is some evidence for its efficacy and multiple rounds of data supporting safety."

Answered by AI

Can people with the qualifying condition join this trial at this time?

"This trial, which was last updated on June 23rd, 2005 is not recruiting patients at this point. However, there are 28 other trials with open recruitment across a variety of medical conditions."

Answered by AI

To whom does this research project offer the opportunity for participation?

"The current study is looking for 132 individuals suffering from herpes simplex that are between 0 and 28 days old. There are a few key requirements potential participants must meet, such as: having a birth weight of at least 800 grams, not being currently nursed by a mother taking acyclovir, valacyclovir, or famciclovir for more than 120 hours or 5 days, and other infants known to be born to HIV positive women cannot participate."

Answered by AI

In how many different locations is this trial being conducted today?

"This study is currently taking place in 26 hospitals, including Children's Hospital of Alabama in Birmingham, University of Arkansas for Medical Sciences in Little Rock, and University of Arkansas in San Antonio."

Answered by AI

Are the participants in this clinical trial restricted to people above a certain age?

"Children that are 0 to 28 days old may be applicable for this clinical trial. There are a total of 6 studies involving minors and 23 with elderly patients."

Answered by AI

Who else is applying?

What state do they live in?
California
Ohio
Texas
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Children's Hospital and Health Center
Connecticut Children's Medical Center
MetroHealth Medical Center
Other
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
1997. "Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00006132.
All > Tennessee > Paid Studies Maine
~5 spots leftby Apr 2025
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