Can a common antiviral tame herpes meningitis?
NCT ID NCT05452928
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether the antiviral drug aciclovir (or its pill form valacyclovir) works better than a placebo for treating meningitis caused by the herpes simplex virus type 2 (HSV-2). About 150 adults with confirmed HSV-2 meningitis will receive either the drug or a placebo, and their symptoms will be scored after 7 days. The goal is to see if the drug speeds up recovery and reduces symptoms like headache, fever, and neck stiffness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aciclovir (also known as valacyclovir)
- What this could lead to
- If it works, this could confirm that aciclovir effectively reduces symptoms of HSV-2 meningitis, providing a standard treatment option.
- What could go wrong
- This is a relatively small Phase 4 trial, and the benefit over placebo may be modest. The primary endpoint is a symptom score, not a cure, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults ≥18 years of age admitted on suspicion of viral meningitis defined as: 1. A clinical presentation consistent with viral meningitis (e.g. headache, nuchal rigidity, photophobia, or fever) AND 2. Cerebrospinal fluid (CSF) pleocytosis (\>4 leukocytes x 106/L) AND 3. HSV-2 positive by PCR of the CSF 4. Glasgow Coma Scale score of 15 AND 5. Ability to absorb oral medications Exclusion Criteria: * Patients fulfilling any of the following criteria will be excluded: 1. Encephalitis as defined by the International Encephalitis Consortium if diagnosed during standard care (see Glossary)20 2. Transverse myelitis as defined by the Transverse Myelitis Consortium Working Group if diagnosed during standard care (see Glossary)21 3. Severe immuno-compromise defined as an ongoing need for biological- or chemotherapy (e.g. natalizumab), prednisolone \>20 mg/day for ≥14 days, uncontrolled HIV/AIDS (see glossary), haematological malignancies, and organ transplant recipients14,18,22 4. Moderate to severe concomitant genital herpes requiring systemic aciclovir 5. Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women) 6. Hepatic impairment (aspartate aminotransferase or alanine aminotransferase levels \>5 times the upper limit of normal) 7. Impaired renal function (estimated glomerular filtration rate \<25 mL/min) 8. Intolerance to (val)aciclovir 9. Probenecid treatment 10. Systemic antiviral therapy with an antiherpetic effect for \>24 hours 11. Previous enrolment into this trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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