Clinical trial NCT01824628: Comparison of the QT/QTc Interval Between an Outpatient HIV-Infected Population on Antiretroviral Therapy and Two Large HIV-Negative Cohorts
Official title: Comparaison Des Intervalles QT/QTc Entre Une Population HIV Positive Ambulatoire Sous thérapie antirétrovirale et Une Population Ambulatoire HIV négative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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 :

1. an outpatient HIV negative population from the same health center pre-admission one-day surgical clinic.
2. 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.

Eligibility criteria: Inclusion Criteria:

* Age eligible for study : 18-65 years old inclusively
* Gender eligible for study : Both

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: QT and corrected QT (QTc) intervals determined by a 12-leads ECG
timeFrame: Day 0 = Day 1 - This is a transversal study.
Secondary outcomes:
measure: Prevalence of QTc interval prolongation in both study groups
timeFrame: Day 0 = Day 1 - This is a transversal study.
measure: To assess risk factors of QTc interval prolongation in both study groups
timeFrame: Day 0 = Day 1 - This is a transversal study.
measure: Prevalence of QT/QTc intervals prolongation and associated risk factors among outpatient HIV subjects
timeFrame: Day 0 = Day 1 - This is a transversal study.
measure: Evaluate the influence of genetic polymorphisms on PI's pharmacokinetic metabolisms in outpatient HIV positive subjects treated with a PI
timeFrame: Day 0 = Day 1 - This is a transversal study
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Unité Hospitalière de Recherche et d'Enseignement et de Soins sur le Sida (UHRESS) ; Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Jacques Turgeon, B. Pharm., M. Sc., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: