Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Apr 26, 2007

Keywords

ClinConnect Summary

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 congenital cytomegalovirus (CMV) disease. Following enrollment, study subjects will receive 6 weeks of oral valganciclovir. Near the end of the 6-week course, subjects will be randomized in a 1:1 fashion either to continue on valganciclovir to complete 6 months of therapy or to begin a matching placebo to complete the 6 months. Study subjects will be stratified according to whether or not there is centr...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 1. Thrombocytopenia
• • 2. Petechiae
• • 3. Hepatomegaly
• • 4. Splenomegaly
• • 5. Intrauterine growth restriction
• • 6. Hepatitis (elevated transaminases and/or bilirubin)
• • 7. 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 Criteria:
• • 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