Comparison of the QT/QTc Interval Between an Outpatient HIV-Infected Population on Antiretroviral Therapy and Two Large HIV-Negative Cohorts (QTVIE)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen

Study type: Observational

Funder types: Other

Identifiers

NCT01824628

CE12.316

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

160 participants in 2 patient groups

• HIV positive subjects receiving antiretroviral regimen

• HIV negative subjects from the pre-admission surgical clinic