An observational study in QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-26.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational
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.
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 :
Secondary objectives :
Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
AIDS status
o Opportunistic infections acquired in the last 30 days before the date of recruitment
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.
Time frame: Day 0 = Day 1 - This is a transversal study.
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.
Time frame: 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.
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
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.
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
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.
Time frame: Day 0 = Day 1 - This is a transversal study
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre hospitalier de l'Université de Montréal (CHUM) →