Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
Completed · Phase 3 · Has a placebo group
Conditions studied: Cytomegalovirus Infection
In brief
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 born with CMV to assess the safety and efficacy of this treatment. Participants will include 104 infants (30 days old or younger) born with CMV disease. All infants will take valganciclovir by mouth for 6 weeks. At the end of the 6 week period, subjects will be assigned by chance to receive either valganciclovir or placebo (inactive substance) to complete the 6 months of antiviral treatment. Patients will be followed for the study related evaluations of safety, changes to hearing, and developmental milestones for up to 2 years. Patients will be followed by telephone contact for an additional 3 years. Thus, participants may be involved in study related procedures for approximately 5 years.
Key facts
- Study ID
- NCT00466817
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 109
- Starts
- 2008-06-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2015-08-26
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama - Children's of Alabama - Clinical Virology — Birmingham, Alabama, United States
- University of South Alabama - Children's Specialty Clinic — Mobile, Alabama, United States
- Arkansas Children's Hospital - Infectious Diseases — Little Rock, Arkansas, United States
- Los Angeles County - University of Southern California - Medical Center - Pediatrics — Los Angeles, California, United States
- Plaza Towers Obstetrics and Gynecology — Los Angeles, California, United States
- Children's Hospital of Orange County - Infectious Diseases — Orange, California, United States
- Stanford University School of Medicine — Stanford, California, United States
- Children's Hospital Colorado - Infectious Disease — Aurora, Colorado, United States
- Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease — Washington D.C., District of Columbia, United States
- University of Florida - College of Medicine - Jacksonville — Jacksonville, Florida, United States
- University of South Florida - Tampa General Hospital - Pediatrics — Tampa, Florida, United States
- Emory Children's Center - Pediatric Infectious Diseases — Atlanta, Georgia, United States
- University of Louisville School of Medicine - Kosair Childrens Hospital - Infectious Diseases — Louisville, Kentucky, United States
- Tulane University - Tulane Medical Center - Pediatrics — New Orleans, Louisiana, United States
- Louisiana State University Health Shreveport - Pediatrics — Shreveport, Louisiana, United States
- Johns Hopkins Children's Center - Pediatric Infectious Diseases — Baltimore, Maryland, United States
- Children's Hospital Boston - Infectious Diseases — Boston, Massachusetts, United States
- University of Minnesota - Pediatric Infectious Disease — Minneapolis, Minnesota, United States
- University of Mississippi - Children's Infectious Diseases — Jackson, Mississippi, United States
- Children's Mercy Hospital and Clinics - Infectious Diseases — Kansas City, Missouri, United States
- Washington University School of Medicine in St. Louis - Center for Clinical Studies — St Louis, Missouri, United States
- Creighton University Medical Center - Medicine - Infectious Diseases — Omaha, Nebraska, United States
- Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases — New Brunswick, New Jersey, United States
- Robert Wood Johnson Medical School - Pediatrics — New Brunswick, New Jersey, United States
- Women & Children's Hospital of Buffalo - Infectious Diseases — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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