Document 0753
 DOCN  M9490753
 TI    Effects of high-dose oral acyclovir on herpesvirus disease and survival
       in patients with advanced HIV disease: a double-blind,
       placebo-controlled study. European-Australian Acyclovir Study Group.
 DT    9411
 AU    Youle MS; Gazzard BG; Johnson MA; Cooper DA; Hoy JF; Busch H; Ruf B;
       Griffiths PD; Stephenson SL; Dancox M; et al; Kobler Centre, St
       Stephen's Clinic, London, UK.
 SO    AIDS. 1994 May;8(5):641-9. Unique Identifier : AIDSLINE MED/94338600
 AB    OBJECTIVE: To determine the efficacy of high-dose oral acyclovir in
       preventing cytomegalovirus (CMV) and other herpesvirus disease in
       patients with advanced HIV disease and to evaluate its effect on patient
       survival. DESIGN: Double-blind, placebo-controlled randomized trial of
       up to 1 year's therapy. SETTING: Outpatient clinics in 16 hospitals in
       Europe and Australia. PARTICIPANTS: A total of 302 patients with Centers
       for Disease Control and Prevention stage IV HIV disease, seropositive
       for CMV and with CD4+ lymphocyte counts < or = 150 x 10(6)/l.
       INTERVENTIONS: Oral acyclovir (800 mg, four times daily) or matching
       placebo for 48 weeks. MAIN OUTCOME MEASURES: Time to development of CMV
       and other herpesvirus disease. Following the results of another study,
       the protocol was amended to make survival a second major endpoint.
       RESULTS: Acyclovir failed to reduce the incidence of CMV disease: the
       probability of developing CMV disease at 1 year was 0.24 and 0.23 in the
       placebo and acyclovir groups, respectively (P = 0.53). However,
       acyclovir significantly reduced the probability of dying at 1 year of
       follow-up (from 0.39 to 0.23; P = 0.018). As expected, acyclovir
       significantly reduced the incidence and frequency of herpes simplex
       virus disease. There were no notable differences between treatment
       groups in clinically adverse experiences and no changes in
       haematological parameters to indicate clinically significant
       drug-induced toxicity. CONCLUSIONS: High-dose acyclovir failed to reduce
       the incidence of CMV disease, but significantly reduced the probability
       of dying at 1 year of follow-up.
 DE    Acquired Immunodeficiency Syndrome/*COMPLICATIONS/MORTALITY
       Acyclovir/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/THERAPEUTIC  USE
       Administration, Oral  Adult  Antiviral Agents/THERAPEUTIC USE
       Australia/EPIDEMIOLOGY  Cytomegalovirus
       Infections/COMPLICATIONS/MORTALITY/PREVENTION &  CONTROL  Double-Blind
       Method  Europe/EPIDEMIOLOGY  Female  Follow-Up Studies  Herpesviridae
       Infections/COMPLICATIONS/MORTALITY/*PREVENTION &  CONTROL  Human  HIV
       Core Protein p24/BLOOD  Leukocyte Count  Male  Middle Age  Pneumonia,
       Pneumocystis carinii/EPIDEMIOLOGY/PREVENTION & CONTROL  Proportional
       Hazards Models  Support, Non-U.S. Gov't  Survival Analysis  Time Factors
       Treatment Outcome  CLINICAL TRIAL  JOURNAL ARTICLE  MULTICENTER STUDY
       RANDOMIZED CONTROLLED TRIAL

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