NCT00001100

Brief Summary

The purpose of this study is to evaluate the benefits and safety of the antiviral drug ganciclovir (DHPG) given intravenously to treat newborn infants who are born infected with cytomegalovirus (CMV). CMV is a herpes virus that can infect most organs of the body, resulting in death in 10-30% of babies with symptoms of CMV. It can cause severe brain damage in a large percentage of surviving babies. Children in this study have a CMV infection of the central nervous system (CNS).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

August 27, 2010

Status Verified

November 1, 2005

First QC Date

November 2, 1999

Last Update Submit

August 26, 2010

Conditions

Cytomegalovirus Infections

Interventions

ganciclovirDRUG

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants may be eligible for this study if they:
  • Were full term infants (at least 32 weeks gestation).
  • Are 1 month of age or younger (preferably less than 2 weeks).
  • Weighed at least 1,200 grams (2.5 lbs) at birth.
  • Have confirmed cytomegalovirus.
  • Have evidence of CMV infection of the CNS with or without evidence of other organ involvement.

You may not qualify if:

  • Infants will not be eligible for this study if they:
  • Have concurrent bacterial infection.
  • Have HIV infection.
  • Have mild symptoms or no symptoms of CMV infection at birth.
  • Have an abnormal brain development (hydranencephaly) or any devastating brain involvement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIAID/DMID/CASG Central Unit

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • Oliver SE, Cloud GA, Sanchez PJ, Demmler GJ, Dankner W, Shelton M, Jacobs RF, Vaudry W, Pass RF, Soong SJ, Whitley RJ, Kimberlin DW; National Institute of Allergy, Infectious Diseases Collaborative Antiviral Study Group. Neurodevelopmental outcomes following ganciclovir therapy in symptomatic congenital cytomegalovirus infections involving the central nervous system. J Clin Virol. 2009 Dec;46 Suppl 4(Suppl 4):S22-6. doi: 10.1016/j.jcv.2009.08.012. Epub 2009 Sep 18.

    PMID: 19766534DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

November 1, 2005

Last Updated

August 27, 2010

Record last verified: 2005-11

Locations

US(1)