Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

NCT05446571 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 3

Started

2023-10-20

Last updated

2026-03-31

Condition(s) studied

Pregnant WomenCMV Infected Fetuses

Investigational drug(s) / intervention(s)

Letermovir →Valacyclovir →

Letermovir: Maternal daily administration of 240 milligrams of letermovir (1x240 mg-tablets) up-until delivery or TOP Placebo of Valaciclovir ; daily administration of 8 grams of valaciclovir (2 g (4 x500 mg-tablets) every 6 hours) up-until delivery or TOP

Valacyclovir: Maternal daily administration of 8 grams of valaciclovir (2 g (4 x500 mg-tablets) every 6 hours) up-until delivery or TOP Placebo of letermovir : (1x240 mg-tablets) up-until delivery or TOP

Study 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 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

CMV PCR in neonatal blood collected — in the first day of life
Negative CMV PCR (\<500 IU/ml) in neonatal blood
CMV PCR in neonatal blood collected — At Termination of pregnancy
Negative CMV PCR (\<500 IU/ml) in cord blood

Trial sites (1)

Facility	City	Region	Status
Hopital Necker - Enfants malades	Paris	France	Recruiting

On this site

📄 Valtrex (valacyclovir) drug profile →

More Assistance Publique - Hôpitaux de Paris trials in France

Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer Recruiting

New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study Recruiting

Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products Recruiting

Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C Recruiting

Periodontitis and Inflammation: Study on Biological Samples Recruiting

Other trials for the same condition

Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section Recruiting

Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB Recruiting

THROmbinography in Pregnant Woman and in Vitro Action of Low Molecular Weight HEparin Recruiting

Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05446571 on ClinicalTrials.gov ↗ ← All trials in France