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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Westmead Hospital
  Westmead, Australia Terminated
• Princess Alexandra Hospital
  Woolloongabba, Australia Terminated

Study contacts

• Study coordinator: Bryan Smith
• Email: Bryan.Smith@amivas.com
• Phone: 301-807-8548

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.