Artesunate combined with standard antiviral therapy for CMV in organ transplant recipients.

Phase 2, Randomized, Open-label, Active Comparator, Dose-ranging Study Evaluating the Efficacy and Safety of Artesunate for Injection in Combination With Ganciclovir or Valganciclovir for the Treatment of Cytomegalovirus Infection in Solid Organ Transplant Recipients

This trial will try adding IV artesunate to standard ganciclovir or oral valganciclovir in adult solid organ transplant patients with CMV to see if it improves viral clearance and safety.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Amivas Inc. (Industry-sponsored)
• Locations: 2 sites (Westmead and 1 other locations)
• Trial ID: NCT06853184 on ClinicalTrials.gov

What this trial studies

This randomized, open-label, active comparator-controlled, dose-ranging Phase 2 trial enrolls adult solid organ transplant recipients with clinically significant CMV DNAemia who require IV ganciclovir or oral valganciclovir. Participants are randomized to receive IV artesunate in combination with IV ganciclovir or oral valganciclovir plus standard of care, versus ganciclovir/valganciclovir monotherapy plus standard of care. Different artesunate dose levels are tested to characterize safety and antiviral effect, with regular virologic monitoring and laboratory safety assessments during treatment and follow-up. The trial is sponsored by Amivas Inc. and conducted at Australian hospital sites.

Who should consider this trial

Good fit: Adults (≥18) who have received a kidney, lung, heart, or liver transplant, have documented CMV DNAemia requiring IV ganciclovir or oral valganciclovir, can be washed out from prior anti-CMV drugs, and meet screening lab and contraceptive requirements are ideal candidates.

Not a fit: Patients with refractory CMV, known CMV antiviral resistance, prior extended ganciclovir/valganciclovir exposure (>8 days), severe liver disease, pregnancy or nursing, or who require interacting medications are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding artesunate could lead to faster viral suppression, fewer CMV-related complications, or reduced need for prolonged antiviral therapy in transplant recipients.

How similar studies have performed: Artesunate has shown antiviral activity against CMV in laboratory studies and limited clinical reports, but robust randomized clinical evidence in transplant patients is currently limited.

Eligibility criteria

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

Where this trial is running

Westmead and 1 other locations

• Westmead Hospital — Westmead, Australia (Recruiting)
• Princess Alexandra Hospital — Woolloongabba, Australia (Recruiting)

Study contacts

• Study coordinator: Lisa Read

Conditions CMV Infection; CMV infection