Not Yet RecruitingPhase 4

Aciclovir Versus Placebo for HSV-2 Meningitis

150 participantsStarted 2026-06-01

Plain-language summary

To determine whether active treatment with (val)acyclovir is superior for treatment of viral meningitis compared with placebo assessed by numbers meeting a primary, objective endpoint at 7 days after randomisation

Who can participate

SexALL

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Inclusion criteria

✓. A clinical presentation consistent with viral meningitis (e.g. headache, nuchal rigidity, photophobia, or fever) AND
✓. Cerebrospinal fluid (CSF) pleocytosis (\>4 leukocytes x 106/L) AND
✓. HSV-2 positive by PCR of the CSF
✓. Glasgow Coma Scale score of 15 AND
✓. Ability to absorb oral medications

Exclusion criteria

✕. Encephalitis as defined by the International Encephalitis Consortium if diagnosed during standard care (see Glossary)20
✕. Transverse myelitis as defined by the Transverse Myelitis Consortium Working Group if diagnosed during standard care (see Glossary)21
✕. 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
✕. Moderate to severe concomitant genital herpes requiring systemic aciclovir
✕. Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women)
✕. Hepatic impairment (aspartate aminotransferase or alanine aminotransferase levels \>5 times the upper limit of normal)
✕. Impaired renal function (estimated glomerular filtration rate \<25 mL/min)
✕. Intolerance to (val)aciclovir

What they're measuring

Primary endpoint (proportion with a Total Morbidity Score)

Timeframe: 7 days since randomisation

Trial details

NCT IDNCT05452928

SponsorJacob Bodilsen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-01

Contact for this trial

Jacob Bodilsen, MD

004597663920 jacob.bodilsen@rn.dk

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