Unité Hospitalière de Recherche et d'Enseignement et de Soins sur le Sida (UHRESS) ; Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
NCT Number: NCT01824628
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.
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Notify Me18 year–65 year
All sexes
Observational
Montreal, Quebec, Canada
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 :
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
o Opportunistic infections acquired in the last 30 days before the date of recruitment
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.
Time frame: Day 0 = Day 1 - This is a transversal study.
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.
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.
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
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.
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Comparaison Des Intervalles QT/QTc Entre Une Population HIV Positive Ambulatoire Sous thérapie antirétrovirale et Une Population Ambulatoire HIV négative
Acronym: QTVIE
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.