AuthorisedTherapeutic use (Phase IV)Interventional

Aciclovir for HSV-2 MENingitis: A double-blinded randomised controlled trial (AMEN)

This research is investigating whether the medicine aciclovir can effectively treat meningitis caused by the herpes simplex virus (HSV-2). Meningitis is an inflammation of the membranes surrounding the brain and spinal cord. Aciclovir is already used to treat certain viral infections. This study is a Phase IV trial, which means it's testing a medicine that's already approved, to gather more information about how it works in a wider group of patients, its safety, and any long-term effects. Participants will receive either aciclovir or a dummy medicine (placebo) that looks identical. Researchers will be carefully checking how patients' symptoms improve, especially their meningitis symptoms, over several days, and looking at their overall health and quality of life over the following months.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Aalborg University Hospital

Enrolment target

150

Start

02 Jan 2025

HSV-2 meningitis

What is this study about?

This study is called AMEN, which stands for Aciclovir for HSV-2 MENingitis. It's designed to find out how well a medicine called aciclovir works for people who have HSV-2 meningitis. HSV-2 is a type of herpes virus that can sometimes cause meningitis, which is when the protective layers around your brain and spinal cord become inflamed. This can lead to symptoms like severe headaches, a stiff neck, and feeling generally unwell.

Even though aciclovir is already used for some viral infections, this particular study is classed as 'Phase IV'. This means it's looking at the medicine in more detail after it's been approved for general use. It helps doctors and researchers understand how the medicine works in typical NHS settings and in a larger and more varied group of patients than earlier trials. They want to see if it truly helps people recover from HSV-2 meningitis.

In this study, some people will receive aciclovir, while others will receive a dummy treatment, called a placebo. Neither the patients nor their doctors will know who is getting which, which helps ensure the results are fair and unbiased. The main thing researchers will be looking at is how much a patient's meningitis symptoms improve after seven days. They'll also be tracking other important things like headaches, any lasting nerve problems, side effects, and how patients' quality of life changes over 3 and 12 months.

Key takeaways

The study is about whether aciclovir helps treat HSV-2 meningitis.
It's a 'Phase IV' study, gathering more information on an already approved medicine.
Participants will receive either aciclovir or a placebo (dummy medicine).
Researchers will monitor symptom improvement, headaches, and quality of life.
Follow-up appointments last for up to 12 months for health checks.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old. There's no upper age limit, and both men and women can take part.

Specifically, you would need to have been diagnosed with meningitis caused by the HSV-2 virus. The research team will go through your medical history and test results to make sure you meet all the necessary requirements for the study.

It's important to understand that there might be other reasons why someone can't join, even if they meet the age and condition criteria. The study doctors will carefully check everything to make sure it's safe and appropriate for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with HSV-2 meningitis?
Are you able to attend follow-up appointments?
Are you willing to potentially receive a placebo?
Are you happy for doctors to collect information about your health over time?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the active medicine, aciclovir, or a dummy medicine (placebo) that looks exactly the same. This would be given to you through a drip into your vein (IV) initially, and then potentially as tablets. Throughout your treatment and for a period after, the study team would regularly check on how you're feeling and how your symptoms are improving.

This would involve doctors regularly checking your meningitis symptoms and how you're doing generally. They would also ask you about any headaches you might have. You would have assessments at 7 days, 3 months, and 12 months after you joined the study. These follow-up appointments would involve checks on your overall health, any remaining symptoms, and potentially filling in questionnaires about your quality of life and thinking abilities. The study team would also monitor for any side effects from the treatment.

Potential risks and benefits

Taking part in this study might offer some potential benefits, such as contributing to medical knowledge that could help future patients with HSV-2 meningitis. If you receive the active drug, there's a chance it could help improve your condition. However, there's also a chance you could receive the placebo. As with any medicine, there is a risk of side effects, which the study doctors will carefully monitor. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is HSV-2 meningitis?

HSV-2 meningitis is an infection of the protective layers around your brain and spinal cord, caused by the herpes simplex virus type 2.

What is aciclovir?

Aciclovir is a medicine that helps fight certain viral infections. This study is testing if it's effective for HSV-2 meningitis.

Will I know if I'm getting the real medicine or a dummy pill?

No, neither you nor your doctor will know if you're getting the active medicine or a placebo. This is to make the study results as fair as possible.

How long will the study last for me?

You will be followed up for a total of 12 months, with checks at 7 days, 3 months, and 12 months after you join.

What does a 'Phase IV' study mean?

It means the medicine is already approved, but researchers want to learn more about how it works in real-world situations and for a larger number of patients.