Back to resultsA Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
Primary Purpose
Cytomegalovirus Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ganciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Cytomegalovirus Infections
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- NIAID/DMID/CASG Central Unit
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001100
First Posted
November 2, 1999
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00001100
Brief Title
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
Official Title
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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).
Detailed Description
The study will enroll 130 newborn infants 1 month of age or younger with CMV involving the CNS. Patients will be assigned randomly (like tossing a coin) to receive either DHPG or no study drug treatment. All babies in the study will receive standard of care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Follow-up evaluations, including hearing and eye exams and developmental assessments, will be done periodically until the child reaches 5 years of age. The degree of improved hearing among surviving patients will be a primary measure of drug effectiveness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ganciclovir
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
NIAID/DMID/CASG Central Unit
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19766534
Citation
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.
Results Reference
derived
Learn more about this trial
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
We'll reach out to this number within 24 hrs