Document 0008
 DOCN  M9580008
 TI    Dose-related difference in progression rates of cytomegalovirus
       retinopathy during foscarnet maintenance therapy. AIDS Clinical Trials
       Group Protocol 915 Team.
 DT    9506
 AU    Holland GN; Levinson RD; Jacobson MA; UCLA Ocular Inflammatory Disease
       Center, Jules Stein Eye; Institute 90024-7003, USA.
 SO    Am J Ophthalmol. 1995 May;119(5):576-86. Unique Identifier : AIDSLINE
       MED/95250862
 AB    PURPOSE: A previous dose-ranging study of foscarnet maintenance therapy
       for cytomegalovirus retinopathy showed a positive relationship between
       dose and survival but could not confirm a relationship between dose and
       time to first progression. This retrospective analysis of data from that
       study was undertaken to determine whether there was a relationship
       between dose and progression rates, which reflects the amount of retina
       destroyed when progression occurs. METHODS: Patients were randomly given
       one of two foscarnet maintenance therapy doses (90 mg/kg of body
       weight/day [FOS-90 group] or 120 mg/kg of body weight/day [FOS-120
       group] after induction therapy. Using baseline and follow-up photographs
       and pre-established definitions and methodology in a masked analysis,
       posterior progression rates and foveal proximity rates for individual
       lesions, selected by prospectively defined criteria, were calculated in
       each patient. Rates were compared between groups. RESULTS: The following
       median rates were greater for the FOS-90 group (N = 8) than for the
       FOS-120 group (N = 10): greatest maximum rate at which lesions enlarged
       in a posterior direction (43.5 vs 12.5 microns/day; P = .002); posterior
       progression rate for lesions closest to the fovea (42.8 vs 5.5
       microns/day; P = .010); and maximum foveal proximity rate for either eye
       (32.3 vs 3.4 microns/day; P = .031). CONCLUSION: Patients receiving
       higher doses of foscarnet have slower rates of progression and therefore
       less retinal tissue damage during maintenance therapy. A foscarnet
       maintenance therapy dose of 120 mg/kg of body weight/day instead of 90
       mg/kg of body weight/day may help to preserve vision in patients with
       cytomegalovirus retinopathy.
 DE    Acquired Immunodeficiency Syndrome/COMPLICATIONS  Adult  AIDS-Related
       Opportunistic Infections/*DRUG THERAPY/  PHYSIOPATHOLOGY  Comparative
       Study  Cytomegalovirus Retinitis/*DRUG THERAPY/*PHYSIOPATHOLOGY  Disease
       Progression  Dose-Response Relationship, Drug  Foscarnet/ADMINISTRATION
       & DOSAGE/*THERAPEUTIC USE  Human  Injections, Intravenous  Male  Middle
       Age  Retinitis/*DRUG THERAPY/PHYSIOPATHOLOGY  Retrospective Studies
       Support, Non-U.S. Gov't  Support, U.S. Gov't, P.H.S.  CLINICAL TRIAL
       JOURNAL ARTICLE  RANDOMIZED CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).