Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

• Status: Not yet recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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 cord blood.

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Letermovir; Valacyclovir

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