title: Oral ganciclovir in children: pharmacokinetics, safety, tolerance, and antiviral effects. The Pediatric AIDS Clinical Trials Group.
abstract: The pharmacokinetics, safety, tolerance, and antiviral effects of ganciclovir (Gcv) administered orally were evaluated in 36 children infected with cytomegalovirus (CMV) who were severely immunocompromised by infection with human immunodeficiency virus type 1. In this dose-escalation study, 30 mg/kg of Gcv administered every 8 h produced serum levels similar to the dose (1 g/8 h) effective for maintenance treatment of CMV retinitis in adults. In older children, serum Gcv concentrations were similar after the administration of capsules and suspension. All doses (10-50 mg/kg/8 h) studied were safe and, except for the volume of suspension or number of pills, were well tolerated. Oral Gcv was associated with a decrease in the detection of CMV by culture or polymerase chain reaction. CMV disease occurred in 3 children during the study: one developed Gcv resistance, another had harbored resistant virus at study entry, and a third had wild-type CMV
authors.affiliation: Divisions of Infectious Diseases and Virology, Dept. of Pediatrics and Laboratory Medicine, University of Washington, Seattle, WA 98105, USA. lfrenkel@u.washington.ed
authors.forename: L M
authors.initials: LM
authors.lastname: Frenkel
authors.forename: E V
authors.initials: EV
authors.lastname: Capparelli
authors.forename: W M
authors.initials: WM
authors.lastname: Dankner
authors.forename: J
authors.initials: J
authors.lastname: Xu
authors.forename: I L
authors.initials: IL
authors.lastname: Smith
authors.forename: A
authors.initials: A
authors.lastname: Ballow
authors.forename: M
authors.initials: M
authors.lastname: Culnane
authors.forename: J S
authors.initials: JS
authors.lastname: Read
authors.forename: M
authors.initials: M
authors.lastname: Thompson
authors.forename: K M
authors.initials: KM
authors.lastname: Mohan
authors.forename: A
authors.initials: A
authors.lastname: Shaver
authors.forename: C A
authors.initials: CA
authors.lastname: Robinson
authors.forename: M J
authors.initials: MJ
authors.lastname: Stempien
authors.forename: S K
authors.initials: SK
authors.lastname: Burchett
authors.forename: A J
authors.initials: AJ
authors.lastname: Melvin
authors.forename: W
authors.initials: W
authors.lastname: Borkowsky
authors.forename: A
authors.initials: A
authors.lastname: Petru
authors.forename: A
authors.initials: A
authors.lastname: Kovacs
authors.forename: R
authors.initials: R
authors.lastname: Yogev
authors.forename: J
authors.initials: J
authors.lastname: Goldsmith
authors.forename: E J
authors.initials: EJ
authors.lastname: McFarland
authors.forename: S A
authors.initials: SA
authors.lastname: Spector
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000188:drug therapy; D000284:Administration, Oral; D000293:Adolescent; D000998:Antiviral Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002214:Capsules; D002648:Child; D002675:Child, Preschool; D003587:Cytomegalovirus / Q000187:drug effects / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000097:blood / Q000517:prevention & control*; D004279:DNA, Viral / Q000097:blood*; D004334:Drug Administration Schedule; D004352:Drug Resistance, Microbial; D004361:Drug Tolerance; D015774:Ganciclovir / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D015497:HIV-1 / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D016867:Immunocompromised Host / Q000187:drug effects; D007223:Infant; D016133:Polymerase Chain Reaction; D013535:Suspensions
chemical_list: D000998:Antiviral Agents; D002214:Capsules; D004279:DNA, Viral; D013535:Suspensions; D015774:Ganciclovir