Document 0755
 DOCN  M9490755
 TI    Efficacy of zidovudine treatment in homosexual men with AIDS-related
       complex: factors influencing development of AIDS, survival and drug
       intolerance. Australian Zidovudine Study Group.
 DT    9411
 AU    Swanson CE; Tindall B; Cooper DA; National Centre in HIV Epidemiology
       and Clinical Research,; University of New South Wales, Australia.
 SO    AIDS. 1994 May;8(5):625-34. Unique Identifier : AIDSLINE MED/94338598
 AB    OBJECTIVES: To investigate (1) the efficacy and safety of zidovudine
       treatment in homo-/bisexual men with AIDS-related complex (ARC) and (2)
       factors associated with development of intolerance to zidovudine.
       DESIGN: A multicentre open-label study. SETTING: Australian public
       hospital system. SUBJECTS: A total of 235 homo-/bisexual men with ARC
       were enrolled. INTERVENTIONS: All subjects received 1200 mg zidovudine
       daily. MAIN OUTCOME MEASURES: Survival, incidence and time to
       development of AIDS and to development of haematological and clinical
       side-effects. RESULTS: Median time to development of AIDS was 61 weeks,
       significantly longer (P < 0.03) than the median of 22 weeks in a small
       control group of 12 untreated ARC subjects. Median survival from
       development of AIDS was 48 weeks, marginally longer than the 44 weeks in
       untreated historical AIDS controls. Anaemia requiring transfusion
       occurred in 113 subjects (48%). Significant differences in time to
       development of AIDS were found in favour of subjects not requiring
       transfusions (P < 0.001) with no weight loss (P = 0.004), and who
       received the full zidovudine dose (1200 mg) during the first 52 weeks of
       treatment (P = 0.021). Significantly longer median survival times from
       commencement of zidovudine were found in subjects with a baseline
       Karnofsky score > or = 90, baseline Hb > or = 13 g/dl, baseline CD4+
       cell count > or = 50 x 10(6)/l, no weight loss during first year of
       treatment, and no or not more than one blood transfusion during
       treatment. The ability to tolerate full-dose zidovudine was best
       predicted by a baseline Hb > or = 13 g/dl. Zidovudine-intolerant
       subjects (defined as the development of either anaemia requiring
       transfusions, WCC 1000 x 10(6)/l or zidovudine-related myopathy) had a
       significantly shorter time to development of AIDS than
       zidovudine-tolerant subjects (P = 0.002). CONCLUSIONS: Zidovudine may
       benefit people with ARC by significantly postponing the development of
       AIDS. This benefit appears to be greater in those who do not develop
       clinical intolerance whilst receiving zidovudine. However,
       administration of zidovudine to subjects with ARC does not appear to
       contribute to improved survival after the development of AIDS. People
       with ARC who develop AIDS while receiving zidovudine, or who develop
       intolerance to zidovudine, should be considered immediately eligible for
       other antiretroviral therapies.
 DE    Acquired Immunodeficiency Syndrome/MORTALITY/PREVENTION & CONTROL  Adult
       Aged  Anemia/CHEMICALLY INDUCED  Australia  AIDS-Related Complex/*DRUG
       THERAPY  AIDS-Related Opportunistic Infections/EPIDEMIOLOGY/PREVENTION &
       CONTROL  Bisexuality  Homosexuality  Human  Life Tables  Likelihood
       Functions  Male  Middle Age  Muscular Diseases/CHEMICALLY INDUCED
       Regression Analysis  Risk Factors  Safety  Severity of Illness Index
       Support, Non-U.S. Gov't  Survival Analysis  Time Factors  Treatment
       Outcome  Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC
       USE  CLINICAL TRIAL  JOURNAL ARTICLE  MULTICENTER STUDY

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