Status:
COMPLETED
Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Infection
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE3
Brief Summary
Cytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The purpose of this study is to compare a 6-week course to a 6-month course of the drug valganciclovir in babies ...
Detailed Description
This study is a multi-center, prospective, international, Phase III, randomized and blinded investigation of 6 weeks versus 6 months of oral valganciclovir therapy in babies with symptomatic congenita...
Eligibility Criteria
Inclusion
- Signed informed consent from parent(s) or legal guardian(s)
- Confirmation of cytomegalovirus (CMV) from urine or throat swab specimens by culture, shell vial, or polymerase chain reaction (PCR) tests
- Symptomatic congenital CMV disease, as manifest by one or more of the following:
- Thrombocytopenia
- Petechiae
- Hepatomegaly
- Splenomegaly
- Intrauterine growth restriction
- Hepatitis (elevated transaminases and/or bilirubin)
- Central nervous system (CNS) involvement of the CMV disease \[such as microcephaly, radiographic abnormalities indicative of CMV CNS disease, abnormal cerebrospinal fluid (CSF) indices for age, chorioretinitis, hearing deficits as detected by formal brainstem evoked response (not a screening auditory brainstem response {ABR}), and/or positive CMV PCR from CSF\]
- Less than or equal to 30 days of age at study enrollment
- Weight at study enrollment greater than or equal to 1800 grams
- Gestational age greater than or equal to 32 weeks at birth
Exclusion
- Imminent demise
- Patients receiving other antiviral agents or immune globulin
- Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
- Documented renal insufficiency, as noted by a creatinine clearance less than 10 mL/min/1.73m\^2 at time of study enrollment
- Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribivir
- Infants known to be born to women who are human immunodeficiency virus (HIV) positive (but HIV testing is not required for study entry)
- Current receipt of other investigational drugs
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00466817
Start Date
June 1 2008
End Date
June 1 2013
Last Update
August 26 2015
Active Locations (48)
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1
University of Alabama - Children's of Alabama - Clinical Virology
Birmingham, Alabama, United States, 35233-1711
2
University of South Alabama - Children's Specialty Clinic
Mobile, Alabama, United States, 36604-3207
3
Arkansas Children's Hospital - Infectious Diseases
Little Rock, Arkansas, United States, 72202-3500
4
Los Angeles County - University of Southern California - Medical Center - Pediatrics
Los Angeles, California, United States, 90033-1075