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Comparing brincidofovir and cidofovir for treating adenovirus infection in children and adults after stem cell transplantation

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating adenovirus infection in patients who have received a stem cell transplant. Adenovirus is a virus that can cause serious complications in people with weakened immune systems, particularly after transplantation procedures. The study compares two medications: brincidofovir and cidofovir, both given through an intravenous infusion (delivery of medication through a vein).

The purpose of this research is to determine how well brincidofovir works compared to cidofovir in treating adenovirus infection in both children and adults who have received a transplant. Both medications are designed to fight viral infections, but they work in slightly different ways. The study will evaluate which treatment is more effective at eliminating the virus from the blood.

During the study, participants will receive either brincidofovir or cidofovir through intravenous infusion. The treatment period may last up to 12 weeks, during which doctors will monitor how well the medications work and check for any side effects. The study team will track various aspects of the participants' health, including how quickly the virus levels decrease and how long patients need to stay in the hospital.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and qualification

    Your eligibility will be assessed if you have received a stem cell transplant within the last 180 days and are at least 2 months old

    The doctor will confirm if you have an adenovirus infection in your blood that requires treatment

    You must not be pregnant or breastfeeding to participate

  2. Step 2

    Random assignment to treatment group

    You will be randomly assigned to receive either brincidofovir or cidofovir through an intravenous infusion (delivered directly into your vein)

    Both medications are designed to treat adenovirus infection

  3. Step 3

    Treatment period

    You will receive your assigned medication through intravenous infusion

    The medical team will monitor your response to treatment

    Regular blood tests will be performed to check virus levels

    Your overall health status will be evaluated throughout the treatment

  4. Step 4

    Safety monitoring

    Your health will be closely monitored for any side effects

    Blood tests and other medical examinations will be conducted regularly

    The medical team will track your hospital stay duration, including any time spent in intensive care

  5. Step 5

    Follow-up period

    You will need to continue using appropriate contraception for 6 months after receiving the last dose of medication

    Your health status will be monitored to check for any return of the virus

    Long-term follow-up will continue to assess your overall health outcomes

Who can join the trial?

7 criteria

  • Must be aged 2 months or older at the time of signing the consent form and have undergone allogeneic stem cell transplantation (a procedure where stem cells from a donor are transferred to the patient) within the last 180 days
  • Must be able to understand and provide written consent to participate in the study (or have a guardian who can provide consent)
  • Must have adenovirus infection in the blood that requires treatment according to the doctor's assessment
  • Women who can become pregnant must agree to use two forms of birth control (including one barrier method) during the study and for 6 months after the last dose of medication
  • Men who can father children must agree to use approved birth control methods during the study and for 6 months after the last dose of medication
  • Female participants must not be pregnant and either not be breastfeeding or willing to stop breastfeeding before starting the study
  • The doctor must determine that the patient's condition requires treatment with either intravenous brincidofovir (given through a vein) or intravenous cidofovir (given through a vein) for adenovirus infection

Who cannot join the trial?

15 criteria

  • Current active cancer treatment (chemotherapy, radiation therapy, or immunotherapy)
  • Known allergy or severe sensitivity to the study medications or their components
  • Severe kidney problems (as measured by blood tests showing poor kidney function)
  • Severe liver problems (as measured by blood tests showing poor liver function)
  • Pregnant women or women who are breastfeeding
  • Active, uncontrolled infections other than adenovirus
  • History of severe allergic reactions to medications
  • Participation in another clinical trial within the past 30 days
  • Unable to follow study procedures or attend scheduled visits
  • Severe heart problems or unstable heart conditions
  • Mental conditions that could interfere with following study requirements
  • Use of certain medications that could interact with study drugs
  • History of organ transplant rejection in the past 14 days
  • Severe breathing problems requiring oxygen support
  • Blood disorders that could increase risk of bleeding
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Investigated drugs

  • Brincidofovir

    An intravenous antiviral medication used to treat adenovirus infections in patients who have received bone marrow transplants. This medication helps fight viral infections by preventing the virus from multiplying in the body.

  • Cidofovir

    An intravenous antiviral medication currently used as a standard treatment for adenovirus infections. It works by interfering with viral DNA replication, helping to stop the spread of the virus in patients who have received bone marrow transplants.

What is already known about the treatment

  • Brincidofovir

    An intravenous antiviral medication that is being investigated for the treatment of adenovirus infections, particularly in patients who have undergone allogeneic hematopoietic cell transplantation. The drug works by inhibiting viral DNA replication through its active metabolite, which interferes with viral DNA polymerase, effectively preventing virus multiplication in infected cells. This novel compound belongs to the class of nucleotide analog antivirals and represents a potential advancement in treating serious viral infections in immunocompromised patients.

  • Cidofovir

    An established intravenous antiviral medication used to treat serious viral infections, particularly effective against adenovirus infections in transplant patients. The drug functions as a cytidine nucleotide analog that selectively inhibits viral DNA polymerase, thereby preventing viral replication in infected cells. It belongs to the antiviral medication class and is currently used as a standard treatment option for adenovirus viremia, though it requires careful monitoring due to its potential for kidney-related side effects.

Investigated diseases

Adenovirus viremia – A condition where adenovirus is present in the bloodstream, indicating an active viral infection. The virus spreads through the blood, potentially affecting multiple organs and tissues in the body. Adenovirus viremia commonly occurs in people with weakened immune systems, particularly after stem cell transplantation. The condition typically begins with the presence of the virus in blood samples and may progress to involve various body systems. The severity of viremia can range from mild to significant, with varying levels of virus detected in the blood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521903-28-00Protocol codeBCV-PA02Estimated enrolment206 patientsSponsorSymbio Pharmaceuticals Ltd.

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