Can a new IV antiviral tame two stubborn viruses?
NCT ID NCT04706923
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial is testing an experimental drug called brincidofovir, given intravenously, in people aged 2 months and older who have an adenovirus or cytomegalovirus infection. The study aims to see how safe and tolerable different doses are, and whether the drug can reduce the amount of virus in the blood. Participants receive the drug twice weekly or once weekly for four weeks, with close monitoring for side effects and antiviral activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brincidofovir (BCV), an experimental antiviral drug given intravenously
- What this could lead to
- If successful, this could lead to a new treatment option for serious adenovirus or cytomegalovirus infections, especially in people with weakened immune systems.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not confirm effectiveness. Possible side effects and safety concerns are still being evaluated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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53 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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May 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 months and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female, aged 2 months and older at the time of informed consent. * AdV DNA viremia \>10,000 copies/mL from a single sample, or 2 samples greater than 48 hours apart with the second result higher than the first and both greater than 1000 copies/mL, from the data obtained from the designated central virology laboratory of the local laboratory using the blood sample(s) collected informed consent has been obtained and within 7 days prior to Day 1 (AdV DNA viremia results collected within the 7 day window, but prior to consent may be used if the Informed Consent Form (ICF) signed by the subject provides approval) . CMV viremia with or without evidence of tissue invasive CMV disease. For laboratory results that are generated in units other than copies/mL or IU/mL, please refer to the testing laboratory for guidance on the appropriate conversion calculation. * Either (a) have disseminated AdV disease or (b) have an underlying immunocompromised state, and have asymptomatic AdV infection or localized AdV disease. * In the judgment of the investigator, be in a serious condition to be treated with intravenous cidofovir for AdV. Exclusion Criteria: * Subjects who weigh ≥120 kg. * NIH/NCI CTCAE (United States \[US\] National Institutes of Health \[NIH\]/National Cancer Institute) Grade 2 or higher diarrhea (i.e., increase of ≥ 4 stools per day over usual pre-transplant stool output) within 7 days prior to Day 1. * NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1. * NIH Stage 2 or higher acute GVHD of the liver function (i.e., bilirubin \>3 mg/dL \[SI: \>51 μmol/L\]) within 7 days prior to Day 1. * NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea \>556 mL/m2/day for pediatric subjects \[or \>1000 mL/day for young adults as applicable, at centers in the United States only\], or severe abdominal pain with or without ileus) within 7 days prior to Day 1.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Research Site
Los Angeles, California, 90027, United States
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Research Site
Los Angeles, California, 90095, United States
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Research Site
San Francisco, California, 94158, United States
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Research Site
Chicago, Illinois, 60637, United States
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Research Site
Durham, North Carolina, 27710, United States
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Research Site
Philadelphia, Pennsylvania, 19104, United States
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Research Site
Seattle, Washington, 98109, United States
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St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A new drug combo may shield kidney transplant patients from a common viral threat
- Blood test could tailor CMV prevention after stem cell transplants
- Can 'Supercharged' donor cells beat viruses that drugs Can't?
- Banked immune cells show promise against Life-Threatening viruses in transplant patients
- Donor immune cells take on tough viruses in transplant patients