A PHASE-I/II TRIAL OF ZIDOVUDINE, INTERFERON-ALPHA, AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR IN THE TREATMENT OF HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 INFECTION

被引:61
作者
DAVEY, RT [1 ]
DAVEY, VJ [1 ]
METCALF, JA [1 ]
ZURLO, JJ [1 ]
KOVACS, JA [1 ]
FALLOON, J [1 ]
POLIS, MA [1 ]
ZUNICH, KM [1 ]
MASUR, H [1 ]
LANE, HC [1 ]
机构
[1] NIH, DEPT CRIT CARE MED, BETHESDA, MD 20892 USA
基金
美国国家卫生研究院;
关键词
D O I
10.1093/infdis/164.1.43
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Twenty-four patients infected with human immunodeficiency virus type 1 (HIV-1) who had CD4+ counts of 0.2-0.5 x 10(9) cells/l received granulocyte-macrophage colony-stimulating factor (GM-CSF) in combination with zidovudine plus escalating doses of daily subcutaneous interferon-alpha. Mean neutropenia-inducing doses of interferon-alpha were 9.4 x 10(6) and 10.6 x 10(6) IU/day for groups receiving 100 or 200 mg zidovudine every 4 h, respectively. Mean GM-CSF doses used to reverse neutropenia were 0.64 and 0.63-mu-g/kg/day for these two groups, respectively, although the mean minimum effective GM-CSF dose for both was only 0.30-mu-g/kg/day. Serum p24 antigen declined > 70% in all 5 antigenemic patients. Toxicities included a dose-dependent increase in lymphokine-like side effects (100%), anorexia and weight loss (42%), fatigue (42%), and anemia (50%). While toxicities of the combination can be significant, low-dose GM-CSF readily ameliorated neutropenia associated with zidovudine and interferon-alpha therapy without adversely affecting the antiviral properties of the combination.
引用
收藏
页码:43 / 52
页数:10
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