Cytomegalovirus RetinitisPhase 4NCT01866397
Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration
A Phase 4 study testing Cidofovir pharmacokinetics in people with Cytomegalovirus Retinitis and Acute Renal Failure, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Cytomegalovirus Retinitis, Acute Renal Failure
- What is being tested?
- Cidofovir pharmacokinetics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2002to Mar 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Cytomegalovirus Retinitis, Acute Renal Failure
- Being tested
- Cidofovir pharmacokinetics
- Keywords
- cidofovir, cvvh, renal replacement therapy, HCMV, Pharmacokinetics of cidofovir during CVVH, continuous venovenous hemofiltration
- Medical subject headings
- Cytomegalovirus Retinitis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cidofovir pharmacokinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
AreaUnderCurve (AUC)
AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration
Measured: 24 hours
Secondary outcomes (6)
half-life (t1/2) of cidofovir during hemofiltration
Measured: 24 hours
maximum and minimum plasma concentration (Cmax, Cmin) of cidofovir during hemofiltration
Measured: 24 hours
total body clearance (Cltot) of cidofovir during hemofiltration
Measured: 24 hours
hemofiltration clearance (ClHF) of cidofovir during hemofiltration
Measured: 24 hours
sieving coefficient of cidofovir during hemofiltration
Measured: 24 hours
elimination fraction of cidofovir during hemofiltration
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMar 2002
- Primary completionMar 2002
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus RetinitisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna
- Responsible party
- Principal investigator, Florian Thalhammer, Medical University of Vienna
- Investigators
- Florian Thalhammer, Prof. MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866397
- Sponsor's protocol ID
- CIDOFOVIR_CVVH
- Status last verified
- Jun 2013
- First submitted
- 28 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration
- ClinicalTrials.gov ID
- NCT01866397
- Acronym / sponsor ID
- CIDOFOVIR_CVVH
- Conditions
- Cytomegalovirus Retinitis, Acute Renal Failure
- Keywords
- cidofovir, cvvh, renal replacement therapy, HCMV, Pharmacokinetics of cidofovir during CVVH, continuous venovenous hemofiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Vienna
- Study start
- Mar 2002
- Primary completion
- Mar 2002 (actual)
- Study completion
- Mar 2002 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cidofovir pharmacokinetics | Experimental | Other: Cidofovir pharmacokineticsPatient 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cidofovir pharmacokineticsBlood 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. | Other | Cidofovir pharmacokinetics |
Primary outcome
AreaUnderCurve (AUC)
Time frame: 24 hours
AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Thalhammer, Prof. MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cidofovir pharmacokinetics in people with Cytomegalovirus Retinitis and Acute Renal Failure, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AreaUnderCurve (AUC) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.