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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ganciclovir; Valganciclovir

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