QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral RegimenQTVIENCT01824628
Comparison of the QT/QTc Interval Between an Outpatient HIV-Infected Population on Antiretroviral Therapy and Two Large HIV-Negative Cohorts
An observational study of QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This is a unicentric, two cohorts, observational transversal study. The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects receiving an antiretroviral therapy and those without HIV in an ambulatory care setting. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Nov 2013
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is being conducted within the Centre hospitalier de l'Université de Montréal (CHUM). The recruited population was identified from the CHUM ambulatory care HIV clinic and an ECG registry composed of outpatient HIV negative subjects who were scheduled for a one-day surgery. The HIV positive outpatients on antiretroviral therapy will be recruited prospectively from March 2013 through August 2013. The outpatient HIV negative cohort will be recruited retrospectively according to a 10:1 ratio.
Who may be able to join
- Age eligible for study : 18-65 years old inclusively
- Gender eligible for study : Both
Who cannot join
- Hospitalised at the moment of recruitment
- AIDS status
- o Opportunistic infections acquired in the last 30 days before the date of recruitment
- Age < 18 years old and > 65 years old
- Follow-up care in an oncology clinic
- Dialysis during the study period
Show all 13Show fewer
- Pregnancy
- Without antiretroviral therapy
- History of a myocardial infarction in the 3 weeks preceding recruitment
- Have a pacemaker
- Diagnosed with bundle branch block on ECG
- Principal follow-up care outside of the CHUM HIV clinic
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Unité Hospitalière de Recherche et d'Enseignement et de Soins sur le Sida (UHRESS) ; Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
About this study
Official title: Comparaison Des Intervalles QT/QTc Entre Une Population HIV Positive Ambulatoire Sous thérapie antirétrovirale et Une Population Ambulatoire HIV négative
This is a unicentric, two cohorts, observational transversal study.
The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects receiving an antiretroviral therapy and those without HIV in an ambulatory care setting.
Read the detailed description
Primary objective:
The primary objective is to compare the QT/QTc intervals of HIV positive subjects treated with antiretroviral therapy and followed at the ambulatory HIV clinic and the QT/QTc intervals of :
- an outpatient HIV negative population from the same health center pre-admission one-day surgical clinic.
- the large HIV-free korean population studied in the ECG-ViEW database.
Secondary objectives :
- Evaluate the prevalence of QTc interval prolongation in the outpatient HIV positive population comparatively to the two HIV negative outpatient populations available from the one-day surgical clinic and the ECG-ViEW database.
- Evaluate risk factors associated with QTc interval prolongation in the outpatient HIV positive population compared to the outpatient HIV negative population and the population studied in the ECG-ViEW database.
- Compare the QT/QTc intervals and the prevalence of QTc interval prolongation of the outpatient HIV positive population currently on an antiretroviral regimen including a protease inhibitor versus those on an antiretroviral regimen without protease inhibitor.
- Compare the QT/QTc intervals among the outpatient HIV positive population treated with a protease inhibitor, in regard to the presence or the absence of certain genetic polymorphisms that may influence pharmacokinetic aspects of protease inhibitors.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| • HIV positive subjects receiving antiretroviral regimen | Not described | |
| • HIV negative subjects from the pre-admission surgical clinic | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT and corrected QT (QTc) intervals determined by a 12-leads ECG
The QT/QTc intervals are determined by a 50 mm/s 12-leads ECG in the outpatient HIV positive population. The ECG is conducted in the morning, between 8:00 and 12:00 to limit the circadian variation.
For the control group, the QT/QTc intervals are assessed through a registry of outpatient HIV negative subjects who had had a standard 12-leads ECG done in pre-admission one-day surgery clinic.
In both groups, the corrected QT interval is calculated with the Bazett's formula and the Fridericia's formula.
Measured: Day 0 = Day 1 - This is a transversal study.
Secondary outcomes (4)
Prevalence of QTc interval prolongation in both study groups
Compare the QTc intervals calculated with the Bazett's formula and the Fridericia's formula in both study groups in order to determine the prevalence of QTc interval prolongation. The QTc interval is considered to be prolonged if it exceeds 430 ms in women and 450 ms in men.
Measured: Day 0 = Day 1 - This is a transversal study.
To assess risk factors of QTc interval prolongation in both study groups
A predetermined questionnaire is filled for each of the study subjects in order to assess factors associated with an increased QTc interval prolongation. This contains demographic information (age, sex, ethnicity...), known health issues (cardiovascular diseases, diabetes, liver diseases...), concomitant drugs, etc.
Measured: Day 0 = Day 1 - This is a transversal study.
Prevalence of QT/QTc intervals prolongation and associated risk factors among outpatient HIV subjects
Compare the QTc intervals calculated with the Bazett's formula and the Fridericia's formula between outpatient HIV positive subjects treated with a protease inhibitor (PI) based antiretroviral regimen and those treated with an antiretroviral regimen without PI. The QTc interval is considered to be prolonged if it exceeds 430 ms in women and 450 ms in men.
Measured: Day 0 = Day 1 - This is a transversal study.
Evaluate the influence of genetic polymorphisms on PI's pharmacokinetic metabolisms in outpatient HIV positive subjects treated with a PI
A blood sample of each subject treated with a PI is analyzed in the laboratory in order to determine whether certain genetic polymorphisms influence on the metabolism of the drug, thus causing a QTc interval prolongation or not.
Measured: Day 0 = Day 1 - This is a transversal study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral RegimenStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Turgeon, B. Pharm., M. Sc., Ph. D., Principal investigator, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824628
- Sponsor's protocol ID
- CE12.316
- Acronym
- QTVIE
- Status last verified
- Nov 2013
- First submitted
- 2 Apr 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison Des Intervalles QT/QTc Entre Une Population HIV Positive Ambulatoire Sous thérapie antirétrovirale et Une Population Ambulatoire HIV négative
- ClinicalTrials.gov ID
- NCT01824628
- Acronym / sponsor ID
- QTVIE / CE12.316
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Apr 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.
This is a unicentric, two cohorts, observational transversal study.
The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects receiving an antiretroviral therapy and those without HIV in an ambulatory care setting.
Detailed description
Primary objective:
The primary objective is to compare the QT/QTc intervals of HIV positive subjects treated with antiretroviral therapy and followed at the ambulatory HIV clinic and the QT/QTc intervals of :
- an outpatient HIV negative population from the same health center pre-admission one-day surgical clinic.
- the large HIV-free korean population studied in the ECG-ViEW database.
Secondary objectives :
- Evaluate the prevalence of QTc interval prolongation in the outpatient HIV positive population comparatively to the two HIV negative outpatient populations available from the one-day surgical clinic and the ECG-ViEW database.
- Evaluate risk factors associated with QTc interval prolongation in the outpatient HIV positive population compared to the outpatient HIV negative population and the population studied in the ECG-ViEW database.
- Compare the QT/QTc intervals and the prevalence of QTc interval prolongation of the outpatient HIV positive population currently on an antiretroviral regimen including a protease inhibitor versus those on an antiretroviral regimen without protease inhibitor.
- Compare the QT/QTc intervals among the outpatient HIV positive population treated with a protease inhibitor, in regard to the presence or the absence of certain genetic polymorphisms that may influence pharmacokinetic aspects of protease inhibitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • HIV positive subjects receiving antiretroviral regimen | – | – |
| • HIV negative subjects from the pre-admission surgical clinic | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is being conducted within the Centre hospitalier de l'Université de Montréal (CHUM). The recruited population was identified from the CHUM ambulatory care HIV clinic and an ECG registry composed of outpatient HIV negative subjects who were scheduled for a one-day surgery. The HIV positive outpatients on antiretroviral therapy will be recruited prospectively from March 2013 through August 2013. The outpatient HIV negative cohort will be recruited retrospectively according to a 10:1 ratio.
Key inclusion criteria (2 listed)
- Age eligible for study : 18-65 years old inclusively
- Gender eligible for study : Both
Key exclusion criteria (13 listed)
- Hospitalised at the moment of recruitment
- AIDS status
- o Opportunistic infections acquired in the last 30 days before the date of recruitment
- Age < 18 years old and > 65 years old
- Follow-up care in an oncology clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QT and corrected QT (QTc) intervals determined by a 12-leads ECG
Time frame: Day 0 = Day 1 - This is a transversal study.
The QT/QTc intervals are determined by a 50 mm/s 12-leads ECG in the outpatient HIV positive population. The ECG is conducted in the morning, between 8:00 and 12:00 to limit the circadian variation. For the control group, the QT/QTc intervals are assessed through a registry of outpatient HIV negative subjects who had had a standard 12-leads ECG done in pre-admission one-day surgery clinic. In both groups, the corrected QT interval is calculated with the Bazett's formula and the Fridericia's formula.
4 secondary outcomes
Prevalence of QTc interval prolongation in both study groups
Time frame: Day 0 = Day 1 - This is a transversal study.
To assess risk factors of QTc interval prolongation in both study groups
Time frame: Day 0 = Day 1 - This is a transversal study.
Prevalence of QT/QTc intervals prolongation and associated risk factors among outpatient HIV subjects
Time frame: Day 0 = Day 1 - This is a transversal study.
Evaluate the influence of genetic polymorphisms on PI's pharmacokinetic metabolisms in outpatient HIV positive subjects treated with a PI
Time frame: Day 0 = Day 1 - This is a transversal study
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 26 Nov 2013.
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.
Jacques Turgeon, B. Pharm., M. Sc., Ph. D. principal investigator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 2 inclusion and 13 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 26 Nov 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 Canada. 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.
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?
QT and corrected QT (QTc) intervals determined by a 12-leads ECG (time frame: Day 0 = Day 1 - This is a transversal study.). 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 26 Nov 2013.