A multicentre open-label study.
SETTING: Australian public hospital system.
SUBJECTS: 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.