A Phase I/II Trial of Zidovudine, Interferon- , and Granulocyte-Macrophage Colony-Stimulating Factor in the Treatment of Human Immunodeficiency Virus Type 1 Infection

Autor: John Zurlo, Kathryn M. Zunich, Victoria J. Davey, Michael A. Polis, Julia A. Metcalf, H. Clifford Lane, Judith Falloon, Henry Masur, Joseph A. Kovacs, Richard T. Davey
Rok vydání: 1991
Předmět:
Zdroj: Journal of Infectious Diseases. 164:43-52
ISSN: 1537-6613
0022-1899
DOI: 10.1093/infdis/164.1.43
Popis: 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 microgram/kg/day for these two groups, respectively, although the mean minimum effective GM-CSF dose for both was only 0.30 microgram/kg/day. Serum p24 antigen declined greater than 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.
Databáze: OpenAIRE