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1994-09-24
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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).