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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
Sponsor:
Collaborator:
University of Vienna
Information provided by (Responsible Party):
Florian Thalhammer, Medical University of Vienna

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Retinitis Acute Renal Failure Other: Cidofovir pharmacokinetics Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

Drug Information available for: Cidofovir

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. AreaUnderCurve (AUC) [ Time Frame: 24 hours ]
    AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration


Secondary Outcome Measures :
  1. half-life (t1/2) of cidofovir during hemofiltration [ Time Frame: 24 hours ]
  2. maximum and minimum plasma concentration (Cmax, Cmin) of cidofovir during hemofiltration [ Time Frame: 24 hours ]
  3. total body clearance (Cltot) of cidofovir during hemofiltration [ Time Frame: 24 hours ]
  4. hemofiltration clearance (ClHF) of cidofovir during hemofiltration [ Time Frame: 24 hours ]
  5. sieving coefficient of cidofovir during hemofiltration [ Time Frame: 24 hours ]
  6. elimination fraction of cidofovir during hemofiltration [ Time Frame: 24 hours ]

Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1190
Sponsors and Collaborators
Medical University of Vienna
University of Vienna
Investigators
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Principal Investigator: Florian Thalhammer, Prof. MD Medical University of Vienna
More Information
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Responsible Party: Florian Thalhammer, a.o.Univ.-Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01866397    
Other Study ID Numbers: CIDOFOVIR_CVVH
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Florian Thalhammer, Medical University of Vienna:
cidofovir
cvvh
renal replacement therapy
 HCMV
Pharmacokinetics of cidofovir during CVVH
continuous venovenous hemofiltration
Additional relevant MeSH terms:
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Cytomegalovirus Retinitis
Retinitis
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Retinal Diseases
Eye Diseases
Eye Infections, Viral
Eye Infections
 Infections
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Cidofovir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action