Aciclovir Versus Placebo for HSV-2 Meningitis

NCT ID: NCT05452928

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2029-06-01

Brief 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

Conditions

Herpes Simplex 2; Meningitis, Viral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active arm

Randomisation to 7 days of active treatment with IV aciclovir 10 mg/kg q8h and possibility for oral step-down therapy with valaciclovir 1g q8h, or placebo (IV q8h and/or oral q8h).

Group Type: ACTIVE_COMPARATOR

Acyclovir 50 MG/ML

Intervention Type: DRUG

Patients are randomised to active treatment with IV acyclovir with the possibility of step-down to valacyclovir. If the treating physician prefers, initial IV treatment can be omitted and the patient can be treated with valacyclovir throughout the study period.

Placebo

Randomisation to 7 days of IV and/or oral placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo either in IV formulation or as tablets identical to valacyclovir tablets.

Interventions

Acyclovir 50 MG/ML

Patients are randomised to active treatment with IV acyclovir with the possibility of step-down to valacyclovir. If the treating physician prefers, initial IV treatment can be omitted and the patient can be treated with valacyclovir throughout the study period.

Intervention Type: DRUG

Placebo

Placebo either in IV formulation or as tablets identical to valacyclovir tablets.

Intervention Type: DRUG

Other Intervention Names

Valacyclovir

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jacob Bodilsen

OTHER

Sponsor Role: lead

Responsible Party

Jacob Bodilsen

Sponsor-investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Jacob Bodilsen, MD

Role: CONTACT

jacob.bodilsen@rn.dk

004597663920

Henrik Nielsen, Professor

Role: CONTACT

henrik.nielsen@rn.dk

004597663920

Other Identifiers

2020-000033-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AMEN1

Identifier Type: -

Identifier Source: org_study_id