A PHASE I SINGLE-DOSE SAFETY EVALUATION AND PHARMACOKINETIC (PKC) STUDY OF NYSTATIN-LF IV IN PATIENTS WITH HIV INFECTION (MEETING ABSTRACT) NLM AIDSLINE Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

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A PHASE I SINGLE-DOSE SAFETY EVALUATION AND PHARMACOKINETIC (PKC) STUDY OF NYSTATIN-LF IV IN PATIENTS WITH HIV INFECTION (MEETING ABSTRACT)

Proc Annu Meet Am Soc Clin Oncol; 11:A18 1992. Unique Identifier : AIDSLINE ICDB/92680749
Rios A; Crofoot GE; Lenk RP; Hayman A; Rosenblum M; Lopez-Berestein G; Twelve Oaks Hosp., Houston, TX

Abstract: Nystatin-LF IV is a lipid-based formulation of nystatin which displays in vitro anti-HIV activity in infected lymphocytes and monocytes. Seventeen male patients with HIV infection were registered on this protocol after informed consent was obtained. Nystatin-LF IV was administered in a single dose in doses ranging from 0.25 mg nystatin to 1.0 mg nystatin/kg body wt. The dose was administered at a rate of 2 mg nystatin/min. No major renal, neurologic, pulmonary or cardiac toxicity was observed. For the PKC studies, samples were obtained in all patients at infusion end, 1, 2, 5, 15, 30, 60, 90, 120, 180 and 480 min after the end of infusion. The max achieved plasma level (CPo) at 1.0 mg/kg was 9 + 0.6 ug/ml. The area under the curve was 1263 +/- 301 mg/ml x min. Clearance from the blood was biphasic. The t1/2a was 7.3 +/- 2.8 min and the t1/2b was 42 + 16 min. There were no dose-dependent changes in PKC Nystatin-LF IV between 0.75 mg/kg dose level and 1.0 mg/kg dose level. Using this information, Phase I-II studies are being planned to define the clinical anti-HIV activity of Nystatin-LF.
Keywords: Antiviral Agents/ADMINISTRATION & DOSAGE/*PHARMACOKINETICS/ *TOXICITY/THERAPEUTIC USE Dose-Response Relationship, Drug Drug Evaluation Human HIV Infections/*DRUG THERAPY Infusions, Intravenous Male Nystatin/ADMINISTRATION & DOSAGE/*PHARMACOKINETICS/*TOXICITY/ THERAPEUTIC USE Time Factors ABSTRACT CLINICAL TRIAL

KWDantiviralagents/administration&dosage/KWDpharmacokinetics/KWDtoxicity/therapeuticusedose-responserelationship,drugdrugevaluationhumanhivinfections/KWDdrugtherapyinfusions,intravenousmalenystatin/administration&dosage/KWDpharmacokinetics/KWDtoxicity/therapeuticusetimefactorsabstractclinicaltrial
921130
M92B0892

Copyright © 1992 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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