Document 0815
 DOCN  M9590815
 TI    Pharmacokinetic, safety, and antiviral profiles of oral ganciclovir in
       persons infected with human immunodeficiency virus: a phase I/II study.
       AIDS Clinical Trials Group, and Cytomegalovirus Cooperative Study Group.
 DT    9509
 AU    Spector SA; Busch DF; Follansbee S; Squires K; Lalezari JP; Jacobson MA;
       Connor JD; Jung D; Shadman A; Mastre B; et al; Dept. of Pediatrics,
       University of California, San Diego, La; Jolla 92093-0672, USA.
 SO    J Infect Dis. 1995 Jun;171(6):1431-7. Unique Identifier : AIDSLINE
       MED/95287032
 AB    A phase I/II study evaluated the pharmacokinetics, tolerability, and
       antiviral activity of oral ganciclovir in persons infected with human
       immunodeficiency virus (HIV). Oral bioavailability ranged from 2.6% to
       7.3%. The mean maximum serum concentration achieved at 1000 mg every 8 h
       was 1.11 micrograms/mL, and mean trough level was 0.54 microgram/mL. The
       time to maximum serum drug concentration was 1.0-2.9 h, with a serum
       half-life of 3.0-7.3 h, suggesting prolonged oral absorption. Serious
       adverse events were uncommon. Decreased cytomegalovirus (CMV) shedding
       was observed from all sites. The median days (by dosage) to retinitis
       progression assessed by retinal examination after initiation of oral
       ganciclovir were 62 (1000 mg every 8 h), 148 (500 mg every 3 h), 75 (750
       mg every 3 h), 148 (1000 mg every 3 h), and 139 (2000 mg every 8 h).
       Thus, oral ganciclovir has pharmacokinetic, toxicity, and antiviral
       profiles that may prove beneficial for both maintenance therapy of CMV
       retinitis and prevention of CMV disease in HIV-infected persons.
 DE    Administration, Oral  Adult  Cytomegalovirus Infections/*DRUG THERAPY
       Cytomegalovirus Retinitis/DRUG THERAPY  Ganciclovir/*ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS/  PHARMACOKINETICS  Human  HIV Infections/*DRUG
       THERAPY  Male  Support, Non-U.S. Gov't  Support, U.S. Gov't, P.H.S.
       CLINICAL TRIAL  CLINICAL TRIAL, PHASE I  JOURNAL ARTICLE

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