CMV Infection
Conditions
Keywords
CMV infection
Brief summary
This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy and SOC treatment in SOT recipients with clinically significant CMV infection.
Interventions
DRUGArtesunate
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: GCV or VGCV and SOC per local institutional practices
Sponsors
Amivas Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of cytomegalovirus (CMV) DNAemia | 28 days | Determine if Artesunate for Injection (intravenous \[IV\] artesunate) when administered in combination with IV Ganciclovir (GCV) and/or oral valganciclovir (VGCV) and standard of care (SOC) treatment impacts change of cytomegalovirus (CMV) DNAemia compared with those who only received GCV or VGCV and SOC treatment |
Countries
Australia
Contacts
Primary ContactLisa Read
Outcome results
None listed