Status:
COMPLETED
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.
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE3
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)....
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 treatme...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00001100
End Date
November 1 2005
Last Update
August 27 2010
Active Locations (1)
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1
NIAID/DMID/CASG Central Unit
Birmingham, Alabama, United States, 35294