A Phase 4 interventional study of Cidofovir pharmacokinetics in Cytomegalovirus Retinitis and Acute Renal Failure, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-06-05.
Sponsored by Medical University of Vienna · Phase 4 and Interventional
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.
64 studies on the registry are indexed under Cytomegalovirus Retinitis; 2 are open to participants now.
This study's enrollment of 1 is below the median of 106 across 38 interventional studies indexed under Cytomegalovirus Retinitis.
Browse Cytomegalovirus Retinitis studies →Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.
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Exclusion Criteria:
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.
AreaUnderCurve (AUC)
AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration
Time frame: 24 hours
half-life (t1/2) of cidofovir during hemofiltration
Time frame: 24 hours
maximum and minimum plasma concentration (Cmax, Cmin) of cidofovir during hemofiltration
Time frame: 24 hours
total body clearance (Cltot) of cidofovir during hemofiltration
Time frame: 24 hours
hemofiltration clearance (ClHF) of cidofovir during hemofiltration
Time frame: 24 hours
sieving coefficient of cidofovir during hemofiltration
Time frame: 24 hours
elimination fraction of cidofovir during hemofiltration
Time frame: 24 hours
The record gives a start of Mar 2002, a primary completion of Mar 2002 and a completion of Mar 2002. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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