In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT01037712
Phase
PHASE4
Status
Terminated

Conditions

  • Cytomegalovirus Infection
  • Viral Disease

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2009
Status verified
Feb 2011
Primary completion
Mar 31, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ZELITREX
    ZELITREX
  • Placebo Comparator: Placebo
    placebo

Primary Outcome Measure

pregnancies with unfavourable exit (symptomatic children at birth or medical interruptions of pregnancy practised for which has appeared cerebral echographic anomalies in connection with the fetal infection with CMV) at 24 hours [ Time Frame: six months ]

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