Comparison of the QT/QTc Interval Between an Outpatient HIV-Infected Population on Antiretroviral Therapy and Two Large HIV-Negative Cohorts (QTVIE)
|ClinicalTrials.gov Identifier: NCT01824628|
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : November 26, 2013
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.
|Condition or disease|
|QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen|
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 Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||Comparaison Des Intervalles QT/QTc Entre Une Population HIV Positive Ambulatoire Sous thérapie antirétrovirale et Une Population Ambulatoire HIV négative|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||November 2013|
|• HIV positive subjects receiving antiretroviral regimen|
|• HIV negative subjects from the pre-admission surgical clinic|
- 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.
- Prevalence of QTc interval prolongation in both study groups [ 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.
- To assess risk factors of QTc interval prolongation in both study groups [ 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.
- 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. ]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.
- 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 ]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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824628
|Unité Hospitalière de Recherche et d'Enseignement et de Soins sur le Sida (UHRESS) ; Centre Hospitalier de l'Université de Montréal (CHUM)|
|Montréal, Quebec, Canada|
|Principal Investigator:||Jacques Turgeon, B. Pharm., M. Sc., Ph. D.||Centre de Recherche du Centre Hospitalier de l'Université de Montréal|