Treating pregnant women with CMV-infected fetuses using Letermovir or Valaciclovir

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of Letermovir and Valaciclovir in treating pregnant women whose fetuses are infected with cytomegalovirus (CMV). The study will assess whether Letermovir can better inhibit fetal CMV replication compared to Valaciclovir, leading to a higher rate of negative CMV PCR results at birth. Additionally, the trial will evaluate the long-term outcomes of neonates, including the incidence of neurological deficiencies and hearing loss, at two years of age. Participants will be monitored for compliance with study visits and procedures throughout the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Hopital Necker - Enfants malades
  Paris, France Recruiting

Study contacts

• Study coordinator: Yves VILLE, MD, PhD
• Email: ville.yves@gmail.com
• Phone: +33 1 71 19 63 32

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.