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Antimicrobial Agents and Chemotherapy, September 1999, p. 2323-2327, Vol. 43, No. 9
0066-4804/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Pharmacokinetics and Safety of High-Dose and Extended-Interval Regimens of Levofloxacin in Human Immunodeficiency Virus-Infected Patients

Stephen C. Piscitelli,1 Katherine Spooner,2,dagger Barbara Baird,2 Andrew T. Chow,3 Cynthia L. Fowler,3 Rex R. Williams,3 Jaya Natarajan,3 Henry Masur,2 and Robert E. Walker4,*

Departments of Pharmacy1 and Critical Care Medicine,2 Warren G. Magnuson Clinical Center, and Laboratory of Immunoregulation,4 National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, and The R. W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey3

Received 2 November 1998/Returned for modification 7 March 1999/Accepted 20 June 1999

The pharmacokinetics of levofloxacin, administered in high doses and with extended dosing intervals, was studied in human immunodeficiency virus (HIV)-infected patients. Thirty patients received either 750 mg of the drug or a placebo once daily for 14 days, followed by 750 mg or 1,000 mg of the drug or a placebo three times weekly for an additional 14 days. Levofloxacin disposition was characterized by rapid oral absorption, with peak concentrations occurring approximately 1.5 h after dosing and elimination half-lives from 7.2 to 9.4 h. The overall incidence of any adverse effect was 70% (1,000 mg) to 95% (750 mg) for levofloxacin-treated patients and 71% for those taking the placebo. Levofloxacin pharmacokinetic parameters for HIV-infected patients were consistent with those observed in studies of healthy volunteers.

* Corresponding author. Mailing address: Bldg. 10, Rm. 11C103, National Institutes of Health, 10 Center Dr. MSC 1880, Bethesda, MD 20892-1880. Phone: (301) 402-0564. Fax: (301) 402-4097. E-mail: rwalker{at}nih.gov.

dagger Present address: Section of Infectious Diseases, National Naval Medical Center, Bethesda, Maryland.

Antimicrobial Agents and Chemotherapy, September 1999, p. 2323-2327, Vol. 43, No. 9
0066-4804/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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