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M9490753.TXT
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1994-09-24
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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).