[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474056":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":31,"responsibleParty":41,"collaborators":31,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":31,"maxAge":31,"enrollmentInfo":55,"targetDuration":31,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":75,"whyStopped":31,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":31},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active arm","ACTIVE_COMPARATOR","Randomisation to 7 days of active treatment with IV aciclovir 10 mg\u002Fkg q8h and possibility for oral step-down therapy with valaciclovir 1g q8h, or placebo (IV q8h and\u002For oral q8h).",[13],"Drug: Acyclovir 50 MG\u002FML",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Randomisation to 7 days of IV and\u002For oral placebo.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Acyclovir 50 MG\u002FML","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.",[9],[27],"Valacyclovir",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo either in IV formulation or as tablets identical to valacyclovir tablets.",[15],null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Jacob Bodilsen, MD","CONTACT","004597663920","jacob.bodilsen@rn.dk",{"name":39,"role":35,"phone":36,"phoneExt":31,"email":40},"Henrik Nielsen, Professor","henrik.nielsen@rn.dk",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Jacob Bodilsen","Sponsor-investigator","100474056","phase-4-aciclovir-versus-placebo-for-hsv-2-meningitis-100474056",false,"NCT05452928","Aciclovir Versus Placebo for HSV-2 Meningitis","Aciclovir for HSV-2 Meningitis: A Double-blind Randomised Controlled Trial (AMEN)","AMEN","Inclusion Criteria:\n\n* Adults ≥18 years of age admitted on suspicion of viral meningitis defined as:\n\n  1. A clinical presentation consistent with viral meningitis (e.g. headache, nuchal rigidity, photophobia, or fever) AND\n  2. Cerebrospinal fluid (CSF) pleocytosis (\\>4 leukocytes x 106\u002FL) AND\n  3. HSV-2 positive by PCR of the CSF\n  4. Glasgow Coma Scale score of 15 AND\n  5. Ability to absorb oral medications\n\nExclusion Criteria:\n\n* Patients fulfilling any of the following criteria will be excluded:\n\n  1. Encephalitis as defined by the International Encephalitis Consortium if diagnosed during standard care (see Glossary)20\n  2. Transverse myelitis as defined by the Transverse Myelitis Consortium Working Group if diagnosed during standard care (see Glossary)21\n  3. Severe immuno-compromise defined as an ongoing need for biological- or chemotherapy (e.g. natalizumab), prednisolone \\>20 mg\u002Fday for ≥14 days, uncontrolled HIV\u002FAIDS (see glossary), haematological malignancies, and organ transplant recipients14,18,22\n  4. Moderate to severe concomitant genital herpes requiring systemic aciclovir\n  5. Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women)\n  6. Hepatic impairment (aspartate aminotransferase or alanine aminotransferase levels \\>5 times the upper limit of normal)\n  7. Impaired renal function (estimated glomerular filtration rate \\\u003C25 mL\u002Fmin)\n  8. Intolerance to (val)aciclovir\n  9. Probenecid treatment\n  10. Systemic antiviral therapy with an antiherpetic effect for \\>24 hours\n  11. Previous enrolment into this trial",true,"ALL",{"count":56,"type":57},150,"ESTIMATED","INTERVENTIONAL",[60],"PHASE4","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",[63,64],"Herpes Simplex 2","Meningitis, Viral",[66,67,68,69,70,71,72,73,74],"meningitis","HSV-2","Herpes simplex 2","viral meningitis","aseptic meningitis","acyclovir","valacyclovir","aciclovir","valaciclovir","NOT_YET_RECRUITING","2025-09-30",{"date":78,"type":79},"2025-10-01","ACTUAL",{"date":81,"type":57},"2026-06-01",{"date":83,"type":57},"2029-06-01",{"name":43,"class":6}]