A phase i/ii trial of zidovudine, interferon-α, and granulocyte-macrophage colony-stimulating factor in the treatment of human immunodeficiency virus type 1 infection

Richard T. Davey, Victoria J. Davey, Julia A. Metcalf, John J. Zurlo, Joseph A. Kovacs, Judith Falloon, Michael A. Polis, Kathryn M. Zunich, Henry Masur, H. Clifford Lane

Research output: Contribution to journalArticle

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Abstract

Twenty-four patients infected with human immunodeficiency virus type 1 (HIV-1) who had CD4+ counts of 0.2-0.5 X 109 cells/l received granulocyte-macrophage colony-stimulating factor (GM-CSF) in combination with zidovudine plus escalating doses of daily subcutaneous inter- feron-a. Mean neutropenia-inducing doses of interferon-α were 9.4 X 106 and 10.6 X 106 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 μg/kg/day for these two groups, respectively, although the mean minimum effective GM-CSF dose for both was only 0.30 μg/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 α therapy without adversely affecting the antiviral properties of the combination.

Original languageEnglish (US)
Pages (from-to)43-52
Number of pages10
JournalJournal of Infectious Diseases
Volume164
Issue number1
DOIs
StatePublished - Jan 1 1991

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Zidovudine
Virus Diseases
Granulocyte-Macrophage Colony-Stimulating Factor
Interferons
HIV-1
Neutropenia
Lymphokines
Anorexia
Therapeutics
CD4 Lymphocyte Count
Antiviral Agents
Fatigue
Anemia
Weight Loss
Antigens
Serum

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Davey, Richard T. ; Davey, Victoria J. ; Metcalf, Julia A. ; Zurlo, John J. ; Kovacs, Joseph A. ; Falloon, Judith ; Polis, Michael A. ; Zunich, Kathryn M. ; Masur, Henry ; Lane, H. Clifford. / A phase i/ii trial of zidovudine, interferon-α, and granulocyte-macrophage colony-stimulating factor in the treatment of human immunodeficiency virus type 1 infection. In: Journal of Infectious Diseases. 1991 ; Vol. 164, No. 1. pp. 43-52.
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abstract = "Twenty-four patients infected with human immunodeficiency virus type 1 (HIV-1) who had CD4+ counts of 0.2-0.5 X 109 cells/l received granulocyte-macrophage colony-stimulating factor (GM-CSF) in combination with zidovudine plus escalating doses of daily subcutaneous inter- feron-a. Mean neutropenia-inducing doses of interferon-α were 9.4 X 106 and 10.6 X 106 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 μg/kg/day for these two groups, respectively, although the mean minimum effective GM-CSF dose for both was only 0.30 μg/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 α therapy without adversely affecting the antiviral properties of the combination.",
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A phase i/ii trial of zidovudine, interferon-α, and granulocyte-macrophage colony-stimulating factor in the treatment of human immunodeficiency virus type 1 infection. / Davey, Richard T.; Davey, Victoria J.; Metcalf, Julia A.; Zurlo, John J.; Kovacs, Joseph A.; Falloon, Judith; Polis, Michael A.; Zunich, Kathryn M.; Masur, Henry; Lane, H. Clifford.

In: Journal of Infectious Diseases, Vol. 164, No. 1, 01.01.1991, p. 43-52.

Research output: Contribution to journalArticle

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