Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01866397

Collaborator

University of Vienna (Other)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Retinitis Acute Renal Failure	Other: Cidofovir pharmacokinetics	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Mar 1, 2002

Actual Study Completion Date :

Mar 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Cidofovir pharmacokinetics Blood samples were drawn before and 15, 30, 60, 120, 240, 360, 720 and 1440 minutes after the start of the cidofovir infusion. Plasma and ultrafiltration samples were collected from the outlet of the ultrafiltrate compartment of the hemofilter.

Arm

Intervention/Treatment

Experimental: 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.

Other: Cidofovir pharmacokinetics

Blood samples were drawn before and 15, 30, 60, 120, 240, 360, 720 and 1440 minutes after the start of the cidofovir infusion. Plasma and ultrafiltration samples were collected from the outlet of the ultrafiltrate compartment of the hemofilter.

Outcome Measures

Primary Outcome Measures

AreaUnderCurve (AUC) [24 hours]
AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.