In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir

NCT01037712 | Terminated Phase 4 DMC

• 1 other identifier: P070115
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Viral Disease; Cytomegalovirus Infection

Keywords

Foetuses infection with CMV; neurological handicap of infectious origin.

Outcome Measures

Primary Outcomes (1)

• 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

  six months

Secondary Outcomes (3)

• the viral load in the blood of the cord of the newborns infected in UTERO by CMV, the compliance at one month the criteria of tolerance

  six months

• the compliance at one month

  six months

• the criteria of tolerance

  six months

Study Arms (2)

ZELITREX

EXPERIMENTAL

ZELITREX

Drug: Valacyclovir (ZELITREX)

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Valacyclovir (ZELITREX) DRUG

2g, 8g/day, 4 a day 23 weeks maximum.

ZELITREX

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years,
• Fetal Infection with CMV authenticated by the positivity of the research of the viral genome by PCR in the amniotic liquid,
• Echographic Assessment revealing at least one cerebral extra anomaly being able to be in connection with the infection with CMV,
• Absence of request for termination of pregnancy from the start,
• Acceptance of a strict follow-up by a Multi-field Center of Prenatal diagnosis and of an optimal observance of the founded treatment,
• Collection of the written assent to take part in the test.
• Affiliation with a mode of social security or equivalent

You may not qualify if:

• No affiliation with a mode of social security (profit or having right)
• Patient of less than 18 years,
• Patient presenting another pathology obstetrical or medical (in particular hepatic or renal) preexistent to tracking or contra-indicating the use of valacyclovir,
• Patients whose fetus does not present any echographic sign being able to be in connection with the infection with CMV,
• Patients whose fetus presents at least one cerebral echographic anomaly:IntraparenchymalVentriculomegaly measured with the ventricular crossroads ≥ 12mm
• Hyperechogenicity periventricular
• Hydrocephaly
• Intra-ventricular adherence
• Microcephaly
• Increase cuts large retro-cerebellar cistern
• Hypoplasia vermis
• Intraparenchymal calcifications
• Porencephaly
• Lissencephaly
• Cysts periventricular

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Necker Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Virus Diseases; Cytomegalovirus Infections

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Infections; Herpesviridae Infections; DNA Virus Infections

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yves VILLE, PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: December 23, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 15, 2012

Record last verified: 2011-02

Locations

FR (1)