Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1)

This research study is trying to find a better way to treat cold sores or genital herpes in people whose immune systems are weakened. These infections are often caused by the herpes simplex virus (HSV) and can be hard to clear up, especially if they don't respond to standard medicines like acyclovir. The study is testing a new drug called pritelivir. Researchers want to compare it to existing treatments to see how effective and safe it is at healing the lesions. It's a Phase 3 study, meaning it's one of the final steps before a new medicine might become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AiCuris Anti-infective Cures AG

Enrolment target

Start

14 Jun 2024

Acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects

What is this study about?

Imagine you have cold sores or genital herpes that just won't go away, even with the usual medicines. This can happen, especially if your immune system isn't working as strongly as it should, perhaps due to another illness or treatment. When these infections don't respond to common antiviral drugs like acyclovir, they are called 'acyclovir-resistant.' This study is designed to see if a new medicine, called pritelivir, can help people in this situation.

The main goal of the study is to find out if pritelivir can successfully heal these stubborn lesions. Researchers will carefully check how many people treated with pritelivir see their lesions heal completely compared to those receiving other established treatments. They will also be looking closely for any side effects to make sure the treatment is safe.

This kind of study, called a 'Phase 3' study, is very important. It's usually the last step before a new medicine can be considered for approval and made available to more people. By taking part, you could be helping to find a new and more effective way to treat these difficult herpes infections.

Key takeaways

This study is for adults with weakened immune systems.
It's for herpes infections (cold sores/genital herpes) that don't respond to usual treatments.
A new medicine called pritelivir is being tested.
The study compares pritelivir to other existing treatments.
It's a 'Phase 3' study, an important step towards new treatments.
Participation involves regular checks and follow-up.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part.

You would be considered for this study if you have a weakened immune system and are currently experiencing cold sores or genital herpes that haven't responded well to common antiviral medications like acyclovir. This means your doctor has tried regular treatments, and the lesions are still there or keep coming back.

There might be other specific health conditions or medications that would prevent someone from joining, so it's always important to discuss your full medical history with the study team.

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?
Do you have a weakened immune system?
Do you currently have cold sores or genital herpes?
Have your herpes lesions not improved with standard medicines like acyclovir?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the new medicine (pritelivir) or one of the existing treatments. This means you wouldn't get to choose which one you receive. You would need to attend regular appointments where the study team will examine your lesions to see if they are healing.

For up to 28 days, you would be taking the study medication. You'd also be asked to keep a daily record of any pain you feel and how severe it is. The team might also take swabs from your lesions to check for the virus. After the main treatment period, there will be follow-up checks at 1, 2, and 3 months to see if your lesions come back.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new drug that could be more effective for your specific condition than current treatments. However, there are also potential risks, as with any medication. You might experience side effects, and the treatment may not work for everyone. All known side effects and risks will be fully explained before you agree to participate. Remember, you can choose to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (5)

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

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Unverified
France
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Unverified
Belgium
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Unverified
Germany
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Unverified
Greece
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Unverified
Italy

Common questions

What is 'acyclovir-resistant' herpes?

It means your cold sores or genital herpes haven't improved with standard medicines like acyclovir.

What kind of new medicine is being tested?

The study is testing a new medicine called pritelivir.

Why is this study important?

It aims to find a better treatment option for people with weakened immune systems whose herpes infections are hard to treat.

Will I know if I'm getting the new medicine or an existing one?

No, you will be randomly assigned to a treatment, and neither you nor the researchers will usually know which one you're getting, to keep the study fair.

How long does treatment usually last in the study?

The main treatment period is up to 28 days, with follow-up appointments after that.