Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

• ClinicalTrials.gov Identifier: NCT01866397
• Recruitment Status: Completed
• First Posted: May 31, 2013
• Last Update Posted: June 5, 2013
• Sponsor: Medical University of Vienna
• Collaborator: University of Vienna
• Information provided by (Responsible Party): Florian Thalhammer, Medical University of Vienna

Tracking Information

• First Submitted Date: May 28, 2013
• First Posted Date: May 31, 2013
• Last Update Posted Date: June 5, 2013
• Study Start Date: March 2002
• Actual Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 4, 2013)

AreaUnderCurve (AUC) [ Time Frame: 24 hours ]

AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration

Original Primary Outcome Measures (submitted: May 30, 2013)

AreaUnderCurve (AUC) [ Time Frame: 24 hours ]

AUC (plasmaconcentration) of cidofovir during 24 hours of hemodiafiltration

Current Secondary Outcome Measures (submitted: June 4, 2013)

• 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 ]

• Original Secondary Outcome Measures (submitted: May 30, 2013): half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction of cidofovir during hemodiafiltration [ Time Frame: 24 hours ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration
• Official Title: Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label)

Condition

• Cytomegalovirus Retinitis
• Acute Renal Failure

Intervention

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.

Study Arms

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.

Intervention: Other: Cidofovir pharmacokinetics

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 30, 2013): 1
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2002
• Actual Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT01866397
• Other Study ID Numbers: CIDOFOVIR_CVVH
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Florian Thalhammer, Medical University of Vienna
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical University of Vienna
• Original Study Sponsor: Same as current
• Collaborators: University of Vienna

Investigators

• Principal Investigator: Florian Thalhammer, Prof. MD; Medical University of Vienna

• PRS Account: Medical University of Vienna
• Verification Date: June 2013