Diseases Studied
The Rare Diseases Clinical Research Network is an NIH-funded research network of 20 active consortia or research groups working to advance treatment for diseases that are rare. Use the search tools on this page to find the diseases we currently study. You can reach out to the indicated consortia or research groups for more information on those diseases and studies underway.
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All Diseases > Cytomegalovirus
Cytomegalovirus (CMV)
Alternative Names: Cytomegalic Inclusion Body Disease/Cytomegalic Inclusion Disease (CIBD/CID)
Disease Category: Congenital Infections
A herpes viral infection resulting in a range of symptoms from no symptoms to severely impacting the central nervous system, spleen, and liver. It is the most common prenatal infection, frequently causing mental disability and sensorineural hearing loss (hearing loss caused by damage to the inner ear or the nerve from the ear to the brain). Immunocompromised individuals are also more susceptible to contracting this infection.
Research groups studying this disease
Congenital Infections
Congenital and Perinatal Infections Consortium (CPIC)
Recruiting
8603: A Phase I, Adaptive, Escalating Single-Dose and Multiple-Dose Pharmacokinetic and Safety Assessment of Letermovir in Infants with Symptomatic Congenital Cytomegalovirus Disease (DMID 21-0027)
Congenital cytomegalovirus (CMV) infection is common and the leading viral cause of sensorineural hearing loss (SNHL) and mental retardation in infants. Despite current treatment options, babies with symptomatic congenital CMV disease are still at risk for hearing loss and neurologic deficits. Letermovir is the first new antiviral treatment of CMV to be licensed in over two decades. Two groups will be enrolled, and letermovir will be administered for 14 days in subjects in both groups. All subjects also will receive valganciclovir as standard of care. Group 1 (n=4) will be given a single dose based on their weight of letermovir on Study Day 0, with a full PK profile obtained over the next 24 hours to verify that the selected dose does not exceed the targeted exposure. Blood specimens will be shipped within approximately 24 hours to the UAB Pharmacokinetic Lab and processed in real time in order to get results back to the study site within an anticipated 7 days. If the drug levels are acceptable, the subject begin a 14-day course of once daily oral letermovir. If the dose is not acceptable, the dose will be adjusted down in 2.5mg increments. Once 4 subjects have been enrolled in group 1, the data and safety monitoring board will review all safety and drug level data. If no concerns are identified, then 8 additional subjects will be enrolled in group 2. The group 2 subject will start the 14 day course of study medication. The dose for group will be based on the data reviewed by the safety committee for the group 1 subjects.
National CMV Foundation
Aims to prevent pregnancy loss, childhood death, and disability due to congenital cytomegalovirus (CMV).