Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

June 4, 2013 updated by: Florian Thalhammer, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1190
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AreaUnderCurve (AUC)
Time Frame: 24 hours
AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

University of Vienna

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (ACTUAL)

March 1, 2002

Study Completion (ACTUAL)

March 1, 2002

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (ESTIMATE)

May 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIDOFOVIR_CVVH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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