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New treatment option for Progressive Multifocal Leukoencephalopathy
Official title Intravenous Brincidofovir as an Antiviral for Treatment of Progressive Multifocal Leukoencephalopathy: A Pilot Study
ClinicalTrials.gov ID: NCT07511049
What this study is testing
What is Brincidofovir?
Brincidofovir is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for progressive multifocal leukoencephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Progressive multifocal leukoencephalopathy (PML) is a rare and often fatal brain infection caused by the JC virus. The JC virus is common.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Able to provide informed consent or have a designated legally authorized representative (LAR) to provide consent
- Stated willingness to comply with study procedures and to participate for the duration of the study including follow-up
- Actively progressing, clinically definite or probable PML (2013 AAN Consensus Diagnostic Criteria)
- Positive PCR for JCPyV in CSF
- Age 18 or older
You likely can't join if
- ALT or AST \> 5 x the ULN, total bilirubin \> 3 mg/dL (SI: \>51 micromol/L), or spontaneous prothrombin time-international normalized ratio (PT-INR)...
- An estimated glomerular filtration rate of \< 30 mL/min within 7 days prior to Day 1
- Hypersensitivity to CDV or to BCV or its formulation excipients, or prior intolerance to these agents that, in the opinion of the investigator, would...
- Active CNS disease other than PML that, in the opinion of the investigator, would confound study assessments or pose an unacceptable safety risk.
- Contraindication to MRI (including cardiac pacemakers and some infusion pumps, other metallic implants, metallic foreign objects)
- Medical contraindication to LP
See the full eligibility criteria
- Able to provide informed consent or have a designated legally authorized representative (LAR) to provide consent
- Stated willingness to comply with study procedures and to participate for the duration of the study including follow-up
- Actively progressing, clinically definite or probable PML (2013 AAN Consensus Diagnostic Criteria)
- Positive PCR for JCPyV in CSF
- Age 18 or older
- Medically stable and able to tolerate travel to NIH
- Participants of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
- ALT or AST \> 5 x the ULN, total bilirubin \> 3 mg/dL (SI: \>51 micromol/L), or spontaneous prothrombin time-international normalized ratio (PT-INR) \> 2 x ULN within 7 days prior to Day 1
- An estimated glomerular filtration rate of \< 30 mL/min within 7 days prior to Day 1
- Hypersensitivity to CDV or to BCV or its formulation excipients, or prior intolerance to these agents that, in the opinion of the investigator, would pose an unacceptable safety risk.
- Active CNS disease other than PML that, in the opinion of the investigator, would confound study assessments or pose an unacceptable safety risk.
- Contraindication to MRI (including cardiac pacemakers and some infusion pumps, other metallic implants, metallic foreign objects)
- Medical contraindication to LP
- Positive pregnancy test or nursing
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.