Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
Condition: Cytomegalovirus Infection
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections
Intervention: Placebo; Valganciclovir
Intervention description: 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.; Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Intervention MeSH terms: Valganciclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 109.0
Sex: All
Maximum age: 30 Days
Healthy volunteers: No
Keywords: Cytomegalovirus, congenital, infants

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.
    

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