Prenatal Treatment of Congenital Cytomegalovirus Infection with Letermovir Versus Valaciclovir

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called Letermovir can better help pregnant women who have a cytomegalovirus (CMV) infected fetus compared to another medication called Valaciclovir. The researchers believe that treating the mother with Letermovir during the first trimester of pregnancy will reduce the amount of CMV in the fetus, leading to more babies being born without the virus in their blood. The trial will also look at how many babies are born without symptoms and any long-term health issues they may have by the age of two.

To participate, women must be at least 18 years old, have had a CMV infection in early pregnancy, and be carrying a fetus between 15 to 28 weeks that has been confirmed to be infected but does not have severe brain abnormalities. Participants will be required to attend study visits and procedures, and they will receive information about what to expect throughout the trial. It's important to note that women with certain health issues or allergies to the study medications will not be eligible to join. This trial is currently recruiting participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant woman ≥ 18 years old,
• • CMV infection in the 1st trimester
• • with an infected fetus at 15 -28 weeks (positive CMV PCR in the amniotic fluid) With a fetus presenting without any severe cerebral ultrasound feature (ventriculomegaly ≥15 mm, hydrocephalus, periventricular hyperechogenicity, microcephaly\<-3SD, vermian hypoplasia, porencephaly, lissencephaly, corpus callosum dysgenesis, cystic leukomalacia)
• • affiliation to a social security regime//health insurance
• • Given consent for the study
• • Patient must be able and willing to comply with study visits and procedures
• • Exclusion Criteria
• • Participation to another interventional drug trial (category 1)
• • Subject protected by law under guardianship or curatorship
• • Maternal CMV infection after 15 weeks'
• • Creatinine clearance \<50 ml/mn/1,73m²
• • Liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN.
• • Woman with known allergy to Letermovir or Valaciclovir
• • Contraindication for the administration of Letermovir and Valaciclovir listed in the SmPC of Prevymis® and Zelitrex®
• • Women with hypersensitivity to aciclovir
• • Concomitant administration of St John's wort
• • Woman treated by pimozide, ergot alkaloids, dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatin or cyclosporin.
• • Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome