Clinical trial NCT01866397: Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration
Official title: Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cytomegalovirus Retinitis
Acute Renal Failure
Keywords: cidofovir
cvvh
renal replacement therapy
HCMV
Pharmacokinetics of cidofovir during CVVH
continuous venovenous hemofiltration
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University of Vienna
First posted: 2013-05-31
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.

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

Primary outcomes:
measure: AreaUnderCurve (AUC)
timeFrame: 24 hours
Secondary outcomes:
measure: half-life (t1/2) of cidofovir during hemofiltration
timeFrame: 24 hours
measure: maximum and minimum plasma concentration (Cmax, Cmin) of cidofovir during hemofiltration
timeFrame: 24 hours
measure: total body clearance (Cltot) of cidofovir during hemofiltration
timeFrame: 24 hours
measure: hemofiltration clearance (ClHF) of cidofovir during hemofiltration
timeFrame: 24 hours
measure: sieving coefficient of cidofovir during hemofiltration
timeFrame: 24 hours
measure: elimination fraction of cidofovir during hemofiltration
timeFrame: 24 hours
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Florian Thalhammer, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: