Recruiting
Phase 2

Artesunate & GCV

Sponsor:

Amivas Inc.

Code:

NCT06853184

Conditions

CMV Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Artesunate

Ganciclovir (GCV)

Study Details

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.

Conditions

CMV Infection

Study ID

NCT06853184

Start date

Aug 1, 2025

Status verified date

Jul, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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

active comparator: Standard Treatment Ganciclovir

Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices

Interventions

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

Primary outcome measure

  • Reduction of cytomegalovirus (CMV) DNAemia [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Bryan Smith

301-807-8548Bryan.Smith@amivas.com

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jaqueline Ferreira, BS

617-643-4179jrferreira@mgh.harvard.edu

Camille Kotton, MD

ckotton@mgh.harvard.edu

Principal Investigator:

Camille Kotton, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Adam Miller

507-266-8147miller.adam@mayo.edu

Raymund Razonable, MD

razonable.raymund@mayo.edu

Principal Investigator:

Raymund Razonable, MD

More Information

Sponsor

Amivas Inc.

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • CMV infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amivas Inc. on 2026-08-03.