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Cited by 60Antifungal resistance and susceptibilityAntibiotics Pharmacokinetics and EfficacyFungal Infections and Studies

A Pharmacokinetic Study of Intravenous Itraconazole Followed by Oral Administration of Itraconazole Capsules in Patients with Advanced Human Immunodeficiency Virus Infection

Zhou, Honghui, Goldman, Mitchell, Wu, Jane, Woestenborghs, Robert, Hassell, Alan E., Lee, Peter, Baruch, Alice, Pesco‐Koplowitz, Luana +2 more·1998·The Journal of Clinical Pharmacology
DOI 10.1002/j.1552-4604.1998.tb04465.x
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Abstract

A randomized, open-label, comparative study was conducted in 30 male patients with moderately advanced human immunodeficiency virus (HIV) infection to examine the pharmacokinetics of an investigational intravenous preparation of itraconazole compared with pharmacokinetics after administration of itraconazole capsules. The study also assessed whether adequate plasma concentrations of itraconazole could be rapidly achieved with the intravenous formulation and then maintained after cessation of intravenous therapy with itraconazole capsules. All patients received 200 mg intravenous itraconazole as a 1-hour infusion in 40% hydroxypropyl-beta-cyclodextrin (HP-beta-CD) vehicle twice daily for 2 days, and then 200 mg intravenously once daily for 5 days. Patients then received itraconazole capsules, either 200 mg twice daily or 200 mg once daily for 28 days. Steady-state plasma concentrations of itraconazole were reached by day 3 with intravenous infusion, a much shorter time than observed with administration of itraconazole capsules. Steady-state concentrations of itraconazole and hydroxyitraconazole were effectively maintained during the rest of the intravenous infusions of itraconazole. Oral follow-up with administration of 200-mg capsules once daily could not maintain the plasma concentrations of itraconazole and hydroxyitraconazole obtained at the end of the intravenous treatment, whereas twice-daily oral administration maintained or increased these concentrations. Mean plasma c…

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Crossref · 10.1002/j.1552-4604.1998.tb04465.x

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  • The intravenous itraconazole formulation was licensed on the basis of evidence that its dosing regimen achieves adequate blood levels more rapidly and with less patient-to-patient variability than do oral preparations of the drug.

    “and was licensed on the basis of evidence that this dosing regimen achieves adequate blood levels more rapidly and with less patient-to-patient variability than do oral preparations of the drug [41][42][43][44].”

    From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [43]

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Authors
Zhou, H., Goldman, M., Wu, J., Woestenborghs, R., Hassell, A. E., Lee, P., Baruch, A., Pesco‐Koplowitz, L., Borum, J., & Wheat, L. J.
Affiliations
  • Novartis (United States) (US)
  • Indiana University Health (US)
Corresponding author
Lee, Peter
ORCID
Venue
The Journal of Clinical Pharmacology
Publisher
Wiley
Published
1998-07
Volume
38
Issue
7
Pages
593-602
ISSN
  • 0021-9754 (ISSN-L)
  • 0091-2700
  • 1552-4604
DOI
10.1002/j.1552-4604.1998.tb04465.x
OpenAlex
W2068225597
Cited by
60
References
27
Citations by year
2024: 1 · 2023: 1 · 2021: 1 · 2020: 1 · 2017: 2 · 2016: 1 · 2015: 3 · 2014: 2 · 2013: 3 · 2012: 2
FWCI
2.76
Type
journal article
Language
en
Open access
closed
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor, 5364 d)
Locations
  • The Journal of Clinical Pharmacology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
  • Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
  • Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
Keywords
itraconazole, pharmacokinetics, HIV infection, intravenous formulation, oral capsules, hydroxypropyl-β-cyclodextrin, hydroxyitraconazole, steady-state plasma concentration, renal clearance, dosing regimen, antifungal therapy
MeSH terms
2-Hydroxypropyl-beta-cyclodextrin, Acquired Immunodeficiency Syndrome, Administration, Oral, Adult, Aged, Antifungal Agents, Cyclodextrins, Female, Humans, Injections, Intravenous, Male, Middle Aged, Itraconazole, beta-Cyclodextrins

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