Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
Condition: Cytomegalovirus Infection
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections; Hearing Loss; Deafness
Intervention: Placebo; Valganciclovir
Intervention description: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks; Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.
Intervention MeSH terms: Valganciclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 1 Month
Maximum age: 4 Years
Healthy volunteers: No
Keywords: CMV; Cytomegalovirus; Hearing Loss; Infants; Valganciclovir

Summary:

      This is an international, multi-center, double-blind, placebo-controlled evaluation
      valganciclovir treatment for up to 54 children (up to 4 years of age) with
      virologically-confirmed congenital CMV infection and hearing loss. Subject participation will
      be over a six-month period and study subjects will be stratified according to age. The
      primary objective is to assess whether a six-week course of oral valganciclovir can stabilize
      the hearing of children with congenital CMV infection who present with hearing loss.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent from parent(s) or legal guardian(s)

          2. Sensorineural hearing loss (>/= 21dB in one or both ears, documented within 12 weeks
             prior to study entry)

          3. Children from 1 month through 3 years of age (up to the 4th birthday)

        Exclusion Criteria:

          1. Imminent demise

          2. Profound sensorineural hearing loss (> 90dB) in both ears

          3. Patients receiving other antiviral agents or immune globulin

          4. Gastrointestinal abnormality which might preclude absorption of an oral medication
             (e.g., a history of necrotizing enterocolitis)

          5. Documented renal insufficiency, as noted by a creatinine clearance < 10 mL/min/1.73m2
             at time of study enrollment

          6. Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet,
             cidofovir, or maribavir

          7. Infants known to be born to women who are HIV positive (but HIV testing is not
             required for study entry).

          8. Current receipt of other investigational drugs

          9. Previous receipt of ganciclovir or valganciclovir

         10. Known hypersensitivity to ganciclovir, valganciclovir, or components of the product

         11. Inability to attend follow-up hearing and clinical assessments

         12. Infants with Auditory neuropathy/dyssynchrony.

         13. Children with another known etiology for SNHL (e.g. connexin 26, syndrome or metabolic
             disorder associated with SNHL, inner ear malformation and widened vestibular
             aqueducts, meningitis).

        Exclusion of each of these conditions is not required for trial enrollment.