Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

Phase 4

Completed

• Conditions: Acute Renal Failure; Cytomegalovirus Retinitis
• Interventions: Other: Cidofovir pharmacokinetics

• Registration Number: NCT01866397
• Lead Sponsor: Medical University of Vienna

Brief Summary

Cidofovir is an acyclic nucleotide analog with broad-spectrum antiviral activity against herpesviruses. Its potency in inhibiting HCMV has been shown in conventional in vitro studies. It is approved for the systemic treatment of human cytomegalovirus (HCMV) retinitis in patients with AIDS and as a second line therapy for HCMV infections not responding to ganciclovir or foscarnet.

In intensive care patients continuous venovenous haemofiltration (CVVH) is a well-established extracorporal renal replacement therapy with a high clearance rate.

Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVH are rare. Elimination of any given drug by renal replacement therapy is determined by several major factors which are membrane specific, due to physico-chemical properties of the drug and characteristics of the renal replacement technique used.

Study objective The trial is conducted to investigate the pharmacokinetics of cidofovir during CVVH in critically ill patients. It is suspected that Hemofiltration will influence cidofovir plasma levels.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2002-03
• Study Completion: 2002-03
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

• Age 18 to 75 years
• Suspected of proven HCMV infection
• Suspected or proven resistancy of HCMV to the first line therapy (ganciclovir / foscarnet).
• Continuous venovenous hemodiafiltration (CVVHDF) due to acute or chronic renal failure.

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Exclusion Criteria

• Known history of hypersensitivity to cidofovir or probenecid.
• An expected survival of less than three days.
• Known alcohol dependency, epilepsy, pregnancy or liver failure.
• Infection with a ganciclovir or foscarnet susceptible HCMV strain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cidofovir pharmacokinetics	Cidofovir pharmacokinetics	Patient received cidofovir due to clinical necessity (therapy resistant HCMV retinitis) while being on continuous hemofiltration. Pre- and postfilter plasma samples were taken at multiple timepoints during 24 hours.

Primary Outcome Measures

Name	Time	Method
AreaUnderCurve (AUC)	24 hours	AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration

Secondary Outcome Measures

Name	Time	Method
maximum and minimum plasma concentration (Cmax, Cmin) of cidofovir during hemofiltration	24 hours
sieving coefficient of cidofovir during hemofiltration	24 hours
half-life (t1/2) of cidofovir during hemofiltration	24 hours
hemofiltration clearance (ClHF) of cidofovir during hemofiltration	24 hours
total body clearance (Cltot) of cidofovir during hemofiltration	24 hours
elimination fraction of cidofovir during hemofiltration	24 hours

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria