52 Participants Needed

IV BCV for Adenovirus Infections

(ATHENA Trial)

Recruiting at 12 trial locations
TY
SK
CY
KS
RM
Overseen ByRochelle Maher
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called brincidofovir (BCV) to assess its safety and tolerability for people with adenovirus (AdV) or cytomegalovirus (CMV) infections. Participants will receive BCV through an IV in varying doses and schedules to determine the most effective method. The trial seeks individuals with significant AdV infection (high levels of the virus in the blood) or CMV who are also in a weakened immune state, making them more susceptible to these viruses. The trial aims to help these patients manage their viral infections more effectively. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that brincidofovir (BCV) is generally safe for people. In one study, patients with adenovirus infections took BCV and showed good tolerance, experiencing no serious side effects. Another study focused on children with adenovirus infections who had stem cell transplants; they also tolerated BCV well, with only a few mild or moderate side effects.

These studies suggest that BCV is usually safe for humans. However, like any medication, it can cause side effects. Prospective participants should discuss any concerns with healthcare providers before considering joining a trial.12345

Why do researchers think this study treatment might be promising for adenovirus infections?

Brincidofovir is unique because it uses a novel approach to tackle adenovirus infections. Unlike the standard antiviral treatments, which often involve oral or topical medications, Brincidofovir is administered intravenously, allowing for a continuous and controlled delivery directly into the bloodstream. This method can enhance the drug's effectiveness by maintaining stable drug levels in the body. Additionally, Brincidofovir's mechanism targets viral DNA polymerase, which is different from many existing treatments, potentially offering a more potent and targeted antiviral action. Researchers are excited about its potential to treat adenovirus infections more effectively and with fewer side effects.

What evidence suggests that this trial's treatments could be effective for adenovirus infections?

Research has shown that brincidofovir (BCV) may help treat adenovirus (AdV) infections. In this trial, participants will receive different dosages of BCV to evaluate its effectiveness. Studies have found that BCV can lower AdV levels in the blood to undetectable levels in more than half of the patients. In some studies, up to 90% of patients eliminated the virus within four weeks of starting treatment. Importantly, these trials revealed no new safety concerns. This suggests that BCV could be a good option for managing AdV infections, especially in people with weakened immune systems.12567

Are You a Good Fit for This Trial?

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

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).
Male or female, aged 2 months and older at the time of informed consent.
Either (a) have disseminated AdV disease or (b) have an underlying immunocompromised state, and have asymptomatic AdV infection or localized AdV disease.
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Exclusion Criteria

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 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.
Subjects who weigh ≥120 kg.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous Brincidofovir (BCV) at varying doses for 4 weeks

4 weeks
8 visits (in-person) for BIW dosing, 4 visits (in-person) for QW dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 weeks
Weekly monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Brincidofovir
Trial Overview The study tests different doses of an intravenous drug called Brincidofovir (BCV) to find a safe and tolerable amount for treating Adenovirus infections. It's given in increasing amounts to see how patients handle it.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: BCV 0.4 mg/kg QWExperimental Treatment1 Intervention
Group II: BCV 0.4 mg/kg BIWExperimental Treatment1 Intervention
Group III: BCV 0.3mg/kg BIWExperimental Treatment1 Intervention
Group IV: BCV 0.2mg/kg BIWExperimental Treatment1 Intervention

Brincidofovir is already approved in United States for the following indications:

🇺🇸
Approved in United States as Tembexa for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

SymBio Pharmaceuticals

Lead Sponsor

Trials
24
Recruited
740+
Founded
2005
Headquarters
Tokyo, Japan
Known For
Rare disease research
Top Products
brincidofovir, bendamustine liquid formulation, rigosertib sodium

Published Research Related to This Trial

Brincidofovir (CMX001) is an effective oral treatment for severe adenoviral pneumonia in renal transplant recipients, especially when intravenous cidofovir causes renal insufficiency.
Brincidofovir has advantages over cidofovir, including better oral bioavailability, no nephrotoxicity, and higher levels of the active drug, making it a safer option for treating adenovirus infections in transplant patients.
Brincidofovir (CMX001) for the Treatment of Severe Adenoviral Pneumonia in Kidney Transplant Recipient.Sudhindra, P., Knoll, B., Nog, R., et al.[2020]
Brincidofovir, a new oral treatment for adenovirus infections, shows promise in being safe and effective in reducing adenovirus levels and related complications in immunosuppressed patients, particularly those undergoing hematopoietic stem cell transplants, as indicated by preliminary results from a phase III clinical trial.
Unlike its predecessor cidofovir, brincidofovir has better cellular uptake and does not cause kidney damage, making it a significant advancement in the treatment of adenovirus infections.
New drug on the horizon for treating adenovirus.Wold, WS., Toth, K.[2020]
Brincidofovir (BCV) has shown promise as a treatment for disseminated adenovirus infections (d-ADV) in pediatric patients after hematopoietic cell transplant (HCT), which are often fatal and have limited treatment options.
In a report involving four pediatric HCT recipients, all were successfully treated with BCV, indicating its potential efficacy in managing this serious infection.
Rapid Virologic Response to Brincidofovir in Children with Disseminated Adenovirus Infection.Chan, SY., Prockop, SE., Boulad, F., et al.[2021]

Citations

Safety and Efficacy of CMX001 as Salvage Therapy for Severe ...We retrospectively analyzed 13 patients with adenovirus disease and viremia treated with CMX001; data were available for ≥4 weeks after initiation of CMX001 ...
NCT02087306 | Study to Assess the Safety and Efficacy of ...The primary efficacy endpoint was the evaluation of the effect of brincidofovir (BCV) on all-cause mortality when used for the treatment of disseminated ...
Preliminary Results of a Phase 2a Clinical Trial to Evaluate ...Adenovirus (AdV) may cause fatal infections in immunosuppressed patients including recipients of allogeneic hematopoietic cell transplant. Brincidofovir (BCV) ...
Preliminary Results from the AdVise Study Evaluating ...AdV viremia was suppressed to undetectable in over half of enrolled subjects. No new safety concerns were identified in this complex patient population. These ...
Preliminary Results of a Phase 2a Clinical Trial to Evaluate ...In Cohort 3, it is notable that 90 % of patients achieved AdV viremia clearance in ≤ 4 weeks of treatment with BCV IV. In Cohorts 2 and 3, all ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/21963623/
Safety and efficacy of CMX001 as salvage therapy ... - PubMedWe retrospectively analyzed 13 patients with adenovirus disease and viremia treated with CMX001; data were available for ≥ 4 weeks after initiation of CMX001 ...
Safety and efficacy of brincidofovir for Adenovirus infection ...Safety and efficacy of brincidofovir for Adenovirus infection in children receiving allogeneic stem cell transplantation: an AIEOP retrospective analyses
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