CMV InfectionPhase 2NCT06853184
Study Evaluating the Efficacy and Safety of Artesunate
A Phase 2 study testing Artesunate and Ganciclovir (GCV) in people with CMV Infection, run by Amivas Inc. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV Infection
- What is being tested?
- Artesunate and Ganciclovir (GCV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Aug 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jaqueline Ferreira, BS, 617-643-4179, jrferreira@mgh.harvard.edu
Camille Kotton, MD, ckotton@mgh.harvard.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Adam Miller, 507-266-8147, miller.adam@mayo.edu
Raymund Razonable, MD, razonable.raymund@mayo.edu
Australia2 sites
- Terminated
Westmead Hospital
Westmead
- Terminated
Princess Alexandra Hospital
Woolloongabba
About this study
Official title: 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 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.
- Conditions
- CMV Infection
- Being tested
- Artesunate, Ganciclovir (GCV)
- Keywords
- CMV infection
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtesunateDrug
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)Drug
Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Artesunate | Experimental | Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices Receives: Drug: Artesunate |
| High Dose Artesunate | Experimental | High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices Receives: Drug: Artesunate |
| Standard Treatment Ganciclovir | Active comparator | Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices Receives: Drug: Ganciclovir (GCV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of cytomegalovirus (CMV) DNAemia
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Aug 2025
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amivas Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853184
- Sponsor's protocol ID
- IVAS-CMV-01
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06853184
- Acronym / sponsor ID
- IVAS-CMV-01
- Conditions
- CMV Infection
- Keywords
- CMV infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Amivas Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Artesunate | Experimental | Drug: ArtesunateLow 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 | Experimental | Drug: ArtesunateHigh 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 | Active comparator | Drug: Ganciclovir (GCV)Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArtesunateLow 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 | Drug | High Dose Artesunate, Low Dose Artesunate |
| Ganciclovir (GCV)Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices | Drug | Standard Treatment Ganciclovir |
Primary outcome
Reduction of cytomegalovirus (CMV) DNAemia
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artesunate and Ganciclovir (GCV) in people with CMV Infection, run by Amivas Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan Smith (301-807-8548, Bryan.Smith@amivas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of cytomegalovirus (CMV) DNAemia (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.