IV BCV for Adenovirus Infections
(ATHENA Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinator or your doctor for guidance.
What data supports the effectiveness of the drug Brincidofovir for treating adenovirus infections?
Research shows that Brincidofovir, a drug related to cidofovir, has been effective in treating severe adenovirus infections in patients with weakened immune systems, such as those who have had organ transplants. It is taken orally and has been shown to reduce the virus in the body without causing kidney damage, which is a common side effect of similar treatments.12345
Is Brincidofovir safe for human use?
Brincidofovir (also known as CMX001) has been used successfully in patients with severe adenovirus infections, including those who are immunocompromised, with reports indicating it is generally safe and well-tolerated. It is noted for having limited toxicity compared to similar treatments and does not cause kidney damage, which is a concern with some other antiviral drugs.12567
How is the drug Brincidofovir different from other treatments for adenovirus infections?
Brincidofovir is unique because it is an oral drug that is a lipid-conjugated form of cidofovir, offering higher levels of the active drug inside cells without the kidney toxicity associated with intravenous cidofovir. It is particularly useful for patients who cannot tolerate other treatments due to kidney issues.12368
What is the purpose of this trial?
The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV
Eligibility Criteria
This trial is for individuals aged 2 months and older with Adenovirus infection, showing high virus levels in the blood. Participants must either have a widespread infection or be immunocompromised with asymptomatic or localized disease. They should need intravenous treatment but can't join if they have severe skin reactions, gut/liver issues from graft-versus-host disease, weigh over 120 kg, or had recent severe diarrhea.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous Brincidofovir (BCV) at varying doses for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Brincidofovir
Brincidofovir is already approved in United States for the following indications:
- Smallpox disease caused by variola virus
Find a Clinic Near You
Who Is Running the Clinical Trial?
SymBio Pharmaceuticals
Lead Sponsor