Pharmacokinetics of recombinant human granulocyte-macrophage colony- stimulating factor: The effects of zidovudine

F. T. Aweeka, M. Kwong, M. Mak, Amira Al-Uzri, M. Affrime, D. Cutler, J. Kahn, J. G. Gambertoglio

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Recombinant human granulocyte-macrophage colony-stimulating factor (rHu GM-CSF) enhances bone marrow production of and stimulates granulocytes, macrophages, and eosinophils. Granulocyte-macrophage colony-stimulating factor may be used concomitantly with zidovudine in human immunodeficiency virus (HIV)-positive patients to minimize zidovudine-associated neutropenia. This open-label, randomized, placebo-controlled study was performed to evaluate the pharmacokinetic disposition of rHu GM-CSF in HIV-positive, asymptomatic patients in the absence and presence of concomitant zidovudine administration. Eight participants received rHu GM-CSF (5 μg/kg subcutaneously) daily for 4 days in combination with placebo or zidovudine (200 mg orally every 8 hours) in a randomized, crossover fashion, with each study period separated by a 3-day washout phase. Pharmacokinetic blood sampling was performed over 16 hours on days 1 and 4 of both treatment periods, and subsequent analysis of serum was performed using an enzyme- linked immunosorbent assay. Pharmacokinetic results of rHu GM-CSF at steady state (days 4 of periods I and II) in the absence (placebo) and presence of zidovudine included apparent total body clearance, half-life, and apparent volume of distribution, all of which were not significantly altered with concomitant administration of zidovudine. Mean pharmacokinetic results of rHu GM-CSF after the first dose (days 1 of periods I and II) were similar to steady-state values; however, total body clearance was significantly increased at steady state compared with the results of the first dose. Concurrent administration of zidovudine does not influence the pharmacokinetic disposition of rHu GM-CSF after single or multiple doses.

Original languageEnglish (US)
Pages (from-to)1107-1113
Number of pages7
JournalJournal of Clinical Pharmacology
Volume36
Issue number12
StatePublished - 1996
Externally publishedYes

Fingerprint

Zidovudine
Granulocyte-Macrophage Colony-Stimulating Factor
Pharmacokinetics
Placebos
HIV
Neutropenia
Granulocytes
Eosinophils
Half-Life
Bone Marrow
Enzyme-Linked Immunosorbent Assay
Macrophages
Demography
Serum

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Aweeka, F. T., Kwong, M., Mak, M., Al-Uzri, A., Affrime, M., Cutler, D., ... Gambertoglio, J. G. (1996). Pharmacokinetics of recombinant human granulocyte-macrophage colony- stimulating factor: The effects of zidovudine. Journal of Clinical Pharmacology, 36(12), 1107-1113.

Pharmacokinetics of recombinant human granulocyte-macrophage colony- stimulating factor : The effects of zidovudine. / Aweeka, F. T.; Kwong, M.; Mak, M.; Al-Uzri, Amira; Affrime, M.; Cutler, D.; Kahn, J.; Gambertoglio, J. G.

In: Journal of Clinical Pharmacology, Vol. 36, No. 12, 1996, p. 1107-1113.

Research output: Contribution to journalArticle

Aweeka, FT, Kwong, M, Mak, M, Al-Uzri, A, Affrime, M, Cutler, D, Kahn, J & Gambertoglio, JG 1996, 'Pharmacokinetics of recombinant human granulocyte-macrophage colony- stimulating factor: The effects of zidovudine', Journal of Clinical Pharmacology, vol. 36, no. 12, pp. 1107-1113.
Aweeka, F. T. ; Kwong, M. ; Mak, M. ; Al-Uzri, Amira ; Affrime, M. ; Cutler, D. ; Kahn, J. ; Gambertoglio, J. G. / Pharmacokinetics of recombinant human granulocyte-macrophage colony- stimulating factor : The effects of zidovudine. In: Journal of Clinical Pharmacology. 1996 ; Vol. 36, No. 12. pp. 1107-1113.
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AU - Kahn, J.

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