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In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir

NCT01651585 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-09-05

No results posted yet for this study

Summary

The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the néonatale viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study. Decrease the fœtal viral load could make possible to decrease symptomatology néonatale in a group of infected fœtuses.

Conditions

  • Foetuses Infection
  • Cytomegalovirus (CMV)Infection

Interventions

DRUG

Valacyclovir arrow

dosage form:500mg, dosage:8g/day, frequency: 4 a day duration: 23 weeks maximum

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • VILLE YVES, MD · Hospital Necker Enfants Malades, Paris France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01651585 on ClinicalTrials.gov