NCT01866397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

Same day

First QC Date

May 28, 2013

Last Update Submit

June 4, 2013

Conditions

Cytomegalovirus RetinitisAcute Renal Failure

Keywords

cidofovircvvhrenal replacement therapyHCMVPharmacokinetics of cidofovir during CVVHcontinuous venovenous hemofiltration

Outcome Measures

Primary Outcomes (1)

  • AreaUnderCurve (AUC)

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

    24 hours

Secondary Outcomes (6)

  • half-life (t1/2) of cidofovir during hemofiltration

    24 hours

  • maximum and minimum plasma concentration (Cmax, Cmin) of cidofovir during hemofiltration

    24 hours

  • total body clearance (Cltot) of cidofovir during hemofiltration

    24 hours

  • hemofiltration clearance (ClHF) of cidofovir during hemofiltration

    24 hours

  • sieving coefficient of cidofovir during hemofiltration

    24 hours

  • +1 more secondary outcomes

Study Arms (1)

Cidofovir pharmacokinetics

EXPERIMENTAL

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

Interventions

Cidofovir pharmacokineticsOTHER

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.

Cidofovir pharmacokinetics

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1190, Austria

Location

MeSH Terms

Conditions

Cytomegalovirus RetinitisAcute Kidney Injury

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsCytomegalovirus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesEye DiseasesRetinitisRetinal DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Florian Thalhammer, Prof. MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
a.o.Univ.-Prof. Dr.

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

March 1, 2002

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

AU(1)