drugset / Trial / NCT01037712

In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir

NCT01037712

Phase 4 Terminated 6 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupDouble-blindTreatment

Summary

The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the neonatal viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fetal 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 against placebo. Decrease the fetal viral load could make possible to decrease symptomatology neonatal in a group of infected fetuses.

Timeline

Start
2009-09
Primary completion
2011-03
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Valacyclovir Unknown 2 g