Document 0938
 DOCN  M9470938
 TI    Randomized double-blind, placebo-controlled trial of twice-daily
       zidovudine in asymptomatic haemophiliacs infected with the human
       immunodeficiency virus type 1. European-Australian Haemophilia
       Collaborative Study Group.
 DT    9409
 AU    Mannucci PM; Gringeri A; Savidge G; Gatenby P; Laurian Y;
       Pabinger-Fasching I; Martinez-Vazquez JM; Hessey EW; Steel HM; Angelo
       Bianchi Bonomi Haemophilia and Thrombosis Centre, Milano,; Italy.
 SO    Br J Haematol. 1994 Jan;86(1):174-9. Unique Identifier : AIDSLINE
       MED/94281072
 AB    In this double-blind, placebo-controlled trial of HIV-infected
       asymptomatic haemophiliacs, the efficacy of 2-year zidovudine therapy
       (1000 mg daily in two divided doses) in preventing progress of HIV
       infection was prospectively evaluated. Drug tolerance was also studied.
       143 haemophiliacs from five European countries and Australia with p24
       antigenaemia and/or CD4 cell counts of 0.1-0.4 x 10(9)/l were enrolled.
       The main measures of outcome were progression to AIDS, CDC group IV
       disease, symptomatic HIV-related disease, and a decrease in CD4+
       T-lymphocyte count to fewer than 0.2 x 10(9)/l. There were no
       significant treatment differences in the proportion of patients
       progressing to AIDS, CDC group IV or symptomatic disease. Analysis of
       time to CD4+ counts less than 0.2 x 10(9)/l showed a non-significant
       trend in favour of zidovudine. Haemoglobin concentrations were less than
       8 g/dl in 4% of zidovudine recipients; neutropenia was less than 0.75 x
       10(9) cells/l in 5% of zidovudine recipients; alanine aminotransferase
       levels were greater than 10 times the upper normal limit in 3% of
       zidovudine recipients, but also in 4% of placebo recipients. Hence there
       was a very low prevalence of side-effects in haemophiliacs, despite the
       use of a higher zidovudine dosage than is currently widely used.
 DE    Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL  Adolescence
       Adult  Aged  Double-Blind Method  Drug Administration Schedule  Female
       Hemophilia/*COMPLICATIONS  Human  HIV Infections/COMPLICATIONS/*DRUG
       THERAPY/IMMUNOLOGY  *HIV-1  Leukocyte Count  Male  Middle Age
       Prospective Studies  Support, Non-U.S. Gov't  T4 Lymphocytes/PATHOLOGY
       Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE  CLINICAL TRIAL  JOURNAL
       ARTICLE  RANDOMIZED CONTROLLED TRIAL

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