Ganciclovir Treatment of Symptomatic Congenital Cytomegalovirus Infection: Results of a Phase II Study. National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group

J Infect Dis. 1997 May;175(5):1080-6. doi: 10.1086/516445.

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Controlled Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Alanine Transaminase / blood
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Aspartate Aminotransferases / blood
  • Bilirubin / blood
  • Central Nervous System Diseases / congenital
  • Central Nervous System Diseases / drug therapy
  • Central Nervous System Diseases / virology
  • Cytomegalovirus / isolation & purification
  • Cytomegalovirus Infections / congenital
  • Cytomegalovirus Infections / drug therapy*
  • Cytomegalovirus Infections / epidemiology
  • Female
  • Ganciclovir / adverse effects
  • Ganciclovir / therapeutic use*
  • Gestational Age
  • Hepatomegaly
  • Humans
  • Incidence
  • Infant, Newborn
  • Infant, Premature
  • Leukocyte Count
  • Male
  • Platelet Count
  • Splenomegaly
  • Time Factors
  • United States / epidemiology
  • Urine / virology

Substances

  • Antiviral Agents
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Ganciclovir
  • Bilirubin