Last updated on July 2020

Asymptomatic Congenital CMV Treatment

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Congenital Cytomegalovirus Infection
  • Age: - 1 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Parent(s)/legal guardian(s) have signed informed consent documents*
  • Confirmation of cytomegalovirus (CMV) by urine polymerase chain reaction (PCR) testing
  • Infant </= 30 days of age at initiation of study drug
  • Weight at study enrollment >/= 1775 grams
  • Gestational age >/= 32 weeks at birth
  • There is a screening informed consent for screening phase of study participation, and a treatment informed consent for treatment phase of study participation.

Exclusion Criteria:

  • Symptomatic congenital cytomegalovirus (CMV) disease*
  • Sensorineural hearing deficits as detected by formal brainstem evoked response (not a screening auditory brainstem response (abr)) of known etiology other than CMV
  • Prior or current receipt of ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
  • Maternal receipt of CMV hyperimmune globulin during pregnancy
  • Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
  • Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
  • Infants known to be born to women who are HIV positive (HIV testing is not required for study entry)
  • Current receipt of other investigational drugs
  • Symptomatic disease is defined as one or more of the following: 1) thrombocytopenia, if known; 2) petechiae; 3) hepatomegaly; 4) splenomegaly; 5) intrauterine growth restriction; 6) hepatitis (elevated transaminases and/or direct bilirubin), if known; 7) central nervous system involvement of the CMV disease (such as microcephaly; radiographic abnormalities indicative of CMV CNS disease, if known; abnormal CSF indices for age, if known; chorioretinitis, if known; and/or positive CMV PCR from CSF, if known).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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