Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-08-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low Dose Artesunate
Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
Artesunate
Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
High Dose Artesunate
High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
Artesunate
Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
Standard Treatment Ganciclovir
Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices
Ganciclovir (GCV)
Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices
Interventions
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Artesunate
Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
Ganciclovir (GCV)
Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Amivas Inc.
INDUSTRY
Responsible Party
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Locations
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Westmead Hospital
Westmead, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IVAS-CMV-01
Identifier Type: -
Identifier Source: org_study_id
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