Congenital Cytomegalovirus (CMV) is an illness that can be transmitted from the mother to baby during pregnancy. This illness can cause many side effects. We will be recruiting families where a child is born with cytomegalovirus which caused hearing loss. Congenital means that this infection occurred before birth.
The purpose of the study is to compare the impact on hearing and language development of infants less than 12 months of age who receive 6 months of the investigational drug, valganciclovir, with children that do not receive the study drug. We also want to learn about the safety and if there are any side effects of giving valganciclovir to these infants. Currently, there is no standard of care to treat these children for hearing loss because of a virus.
Valganciclovir is the liquid form of another drug, ganciclovir. Valganciclovir can be taken by mouth and then turns into ganciclovir in the bloodstream. Valganciclovir works well against CMV in adult human clinical studies and in laboratory tests. It is approved for treatment of CMV by the Food and Drug Administration (FDA) in pill form for adults only. Recently, valganciclovir liquid was approved by the FDA to prevent CMV disease in children older than 4 months of age that have had a kidney and/or heart transplant.
Because congenital CMV-associated hearing loss can continue to get worse over the first years of a child’s life, it would be helpful if we had a medicine that could improve the chance that hearing will stabilize or improve. Past studies have shown that giving 6 weeks of intravenous ganciclovir or 6 months of oral ganciclovir (valganciclovir) to newborns with severe “symptomatic” congenital CMV disease reduces hearing loss; therefore, we would like to study if giving valganciclovir to children under 6 months of age with a less severe CMV infection (hearing loss only) would reduce hearing loss.
Study Procedures Overview
- 6 months of study drug (valganciclovir or placebo)
- Blood draws to monitor safety and to look at how the drug works in the body
- Phone surveys to assess speech and communication when the patient is around 14 and 20 months of age
- The study team will be obtaining data from hearing exams that occur during the study period
- At visits answering questions related to patient’s past medical history, medication use, family history, study drug use, and any doctor or hospital visits while taking the study drug
What does ValEAR mean?
ValEAR comes from the title of the study. It is a combination of “Val” from Valganciclovir and “EAR” from the word hearing.
This short study name makes it easier for people working on the study to talk about it.