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Completed

NCT Number: NCT01866397

Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration

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.

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Key information

Conditions

Cytomegalovirus Retinitis Acute Kidney Injury Acute Renal Failure Cytomegalovirus Infections DNA Virus Infections Eye Diseases Eye Infections Eye Infections, Viral Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Herpesviridae Infections Infections Kidney Diseases Male Urogenital Diseases Renal Insufficiency Retinal Diseases Retinitis Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna

Vienna, 1190, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cidofovir pharmacokinetics

Other

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.

Primary outcomes

  1. AreaUnderCurve (AUC)

    Time frame: 24 hours

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • University of Vienna

Registry information

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
May 31, 2013
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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