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Malaria drug could help fight dangerous virus in transplant patients

NCT ID NCT06853184

Disease control Sponsor: Amivas Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tests whether adding the malaria drug artesunate to standard antiviral treatment can better control cytomegalovirus (CMV) infection in people who have received a solid organ transplant (kidney, lung, heart, or liver). About 90 adult participants will receive either a low or high dose of artesunate plus standard care, or standard care alone. The goal is to see if the combination reduces the amount of virus in the blood more effectively than standard treatment alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
artesunate (an antimalarial drug) combined with ganciclovir or valganciclovir (standard antiviral drugs)
What this could lead to
If it works, this could offer a new combination treatment to better control CMV infections in transplant patients, potentially reducing complications.
What could go wrong
This is an early Phase 2 trial with only 90 participants, so results may not apply to everyone. The added benefit of artesunate is unproven, and side effects from the combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be at least 18 years of age * Recipient of a solid organ transplant (kidney, lung, heart, or liver) * Have a documented CMV infection * Have CMV DNAemia * Require IV GCV or oral VGCV * Be washed out from any anti-CMV antiviral drugs * Have all the following results as part of screening laboratory assessments * Have life expectancy of ≥ 12 weeks * Be willing and have an understanding and ability to fully comply with the study * If female use birth control Exclusion Criteria: * Have taken IV GCV or oral VGC daily for \>8 days * Have refractory CMV infection or disease * Have CMV antiviral drug resistance * Have a known hypersensitivity to artesunate, GCV, or VGCV * Pregnant (or expecting to conceive) or nursing * Have severe liver disease * Require ongoing treatment with or an anticipated need for treatment with drugs with known interactions with artesunate or GCV * Taking any another investigational drug with anti-CMV activity

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CMV infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Princess Alexandra Hospital

    TERMINATED

    Woolloongabba, Australia

  • Westmead Hospital

    TERMINATED

    Westmead, Australia

More trials for these conditions

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