Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
Key facts
- Phase
- Phase 3
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- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05446571
- Record updated
- 31 March 2026
- Original description
The investigators' hypothesis is that maternal treatment with Letermovir will inhibit fetal CMV replication better than Valaciclovir in infected fetuses and lead to a higher proportion of negative CMV PCR at birth in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP).Read full original descriptionShow less
Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir (Step 2)
The investigators' hypothesis is that maternal treatment with Letermovir will inhibit fetal CMV replication better than Valaciclovir in infected fetuses and lead to a higher proportion of negative CMV PCR at birth in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP).
The main objective is to demonstrate that Letermovir administered to women carrying a CMV infected fetus following a maternal infection of the first trimester increases the proportion of neonates with a negative CMV PCR in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP) compared to Valaciclovir.
In each group , the proportion of asymptomatic neonates and the number and type of long-term sequelae at 2 years will also be assessed and compared.
Inclusion: 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: Participation to another interventional drug trial (category 1); Concomitant administration of St John's wort; Maternal CMV infection after 15 weeks'; Woman with known allergy to Letermovir or Valaciclovir; Women with hypersensitivity to aciclovir; Creatinine clearance <50 ml/mn/1,73m²; Liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN; Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome; Subject protected by law under guardianship or curatorship; Contraindication for the administration of Letermovir and Valaciclovir listed in the SmPC of Prevymis® and Zelitrex®; Woman treated by pimozide, ergot alkaloids, dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatin or cyclosporin.