Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: results of a phase II study. National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group.

Academic Article


  • Congenital cytomegalovirus (CMV) infection occurs in approximately 1% of newborns in the United States. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively. Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (< or = 50,000/mm3) in 37 babies and absolute neutropenia (< or = 500 mm3) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy.
  • Published In


  • Alanine Transaminase, Antiviral Agents, Aspartate Aminotransferases, Bilirubin, Central Nervous System Diseases, Cytomegalovirus, Cytomegalovirus Infections, Female, Ganciclovir, Gestational Age, Hepatomegaly, Humans, Incidence, Infant, Newborn, Infant, Premature, Leukocyte Count, Male, Platelet Count, Splenomegaly, Time Factors, United States, Urine
  • Digital Object Identifier (doi)

    Author List

  • Whitley RJ; Cloud G; Gruber W; Storch GA; Demmler GJ; Jacobs RF; Dankner W; Spector SA; Starr S; Pass RF
  • Start Page

  • 1080
  • End Page

  • 1086
  • Volume

  • 175
  • Issue

  • 5