Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration
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|ClinicalTrials.gov Identifier: NCT01866397|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : June 5, 2013
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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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||March 2002|
|Actual Study Completion Date :||March 2002|
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.
- AreaUnderCurve (AUC) [ Time Frame: 24 hours ]AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration
- 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 ]
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866397
|Medical University of Vienna|
|Vienna, Austria, 1190|
|Principal Investigator:||Florian Thalhammer, Prof. MD||Medical University of Vienna|
|Responsible Party:||Florian Thalhammer, a.o.Univ.-Prof. Dr., Medical University of Vienna|
|Other Study ID Numbers:||
|First Posted:||May 31, 2013 Key Record Dates|
|Last Update Posted:||June 5, 2013|
|Last Verified:||June 2013|
renal replacement therapy
Pharmacokinetics of cidofovir during CVVH
continuous venovenous hemofiltration
Acute Kidney Injury
Eye Infections, Viral
DNA Virus Infections
Molecular Mechanisms of Pharmacological Action