Testing a new antiviral drug for infants with congenital cytomegalovirus disease
Letermovir Phase I Trial
This study is looking at how safe and effective the antiviral medicine Letermovir is for infants with congenital cytomegalovirus (CMV) disease, and by joining, your baby will get special care and monitoring to help find better treatments for this condition that can cause hearing loss and other problems.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Alabama at Birmingham NIH-funded |
| Lab location | 1 site (Birmingham, United States) |
| Project ID | NIH-10915388 on NIH RePORTER |
What this research studies
This research investigates the safety and effectiveness of Letermovir, an antiviral medication, in infants diagnosed with symptomatic congenital cytomegalovirus (CMV) disease. The study will assess how the drug is processed in the body through single and multiple doses, focusing on its pharmacokinetics and safety profile. By participating, infants will receive close monitoring and care as part of the trial, which aims to improve treatment options for this condition. The research is crucial as congenital CMV is a leading cause of hearing loss and neurological issues in newborns.
Who could benefit from this research
Good fit: Ideal candidates for this research are infants diagnosed with symptomatic congenital cytomegalovirus disease.
Not a fit: Patients who are not infants or those without a diagnosis of symptomatic congenital CMV disease may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to improved treatment options for infants affected by congenital CMV, potentially reducing the incidence of hearing loss and other neurological complications.
How similar studies have performed: While antiviral treatments for CMV exist, this specific approach using Letermovir in infants is novel and has not been extensively tested in this population.
Where this research is happening
Birmingham, United States
- University of Alabama at Birmingham — Birmingham, United States (Active)
Researchers
- Principal investigator: Kimberlin, David W — University of Alabama at Birmingham
- Study coordinator: Kimberlin, David W
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.