A dose escalation study to determine the toxicity and maximally tolerated dose of foscarnet. NLM AIDSLINE Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.

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A dose escalation study to determine the toxicity and maximally tolerated dose of foscarnet.

AIDS. 1993 Jul;7(7):941-5. Unique Identifier : AIDSLINE MED/93363257
Seidel EA; Koenig S; Polis MA; Laboratory of Immunoregulation, NIAID, NIH, Bethesda, MD 20892.

Abstract: OBJECTIVE: To determine the maximum tolerated dose of intravenous foscarnet (trisodium phosphonoformate hexahydrate); and to examine antiviral activity at plasma levels shown to inhibit HIV-1. DESIGN: Dose escalation study in three male subjects with AIDS who received foscarnet by continuous intravenous infusion at a dose of 200 mg/kg per day, after a 20 mg/kg loading dose. The dose was increased until a plasma level > 150 micrograms/ml was attained. RESULTS: Foscarnet was discontinued due to progressive renal insufficiency in all three patients (days 11, 19, and 21). Renal function normalized in all three, and no adverse sequelae due to foscarnet were observed at 1 year of follow-up. A seizure was observed in one patient on day 19. Maximum daily doses of foscarnet achieved were 395 mg/kg, 389 mg/kg, and 523 mg/kg. No changes in serum Ca2+, Mg2+, or PO4- were observed. CONCLUSIONS: Renal effects and toxicity of foscarnet in evolving renal insufficiency is self-limiting and reversible when the drug is discontinued. Incremental increases in dose can result in rapid rises in the plasma level with renal failure and may be compounded by concomitant medications and underlying illnesses.
Keywords: Acquired Immunodeficiency Syndrome/COMPLICATIONS/*DRUG THERAPY Adult Case Report Creatinine/BLOOD Dose-Response Relationship, Drug Foscarnet/ADMINISTRATION & DOSAGE/*TOXICITY Human HIV-1/*DRUG EFFECTS Infusions, Intravenous Kidney Failure/COMPLICATIONS Male Middle Age Seizures/COMPLICATIONS CLINICAL TRIAL CLINICAL TRIAL, PHASE I JOURNAL ARTICLEKWDacquiredimmunodeficiencysyndrome/complications/KWDdrugtherapyadultcasereportcreatinine/blooddose-responserelationship,drugfoscarnet/administration&dosage/KWDtoxicityhumanhiv-1/KWDdrugeffectsinfusions,intravenouskidneyfailure/complicationsmalemiddleageseizures/complicationsclinicaltrialclinicaltrial,phaseijournalarticle
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M93C0753

Copyright © 1993 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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