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

NCT ID: NCT01824628

Last Updated: 2013-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-11-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

• HIV positive subjects receiving antiretroviral regimen

No interventions assigned to this group

• HIV negative subjects from the pre-admission surgical clinic

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Turgeon, B. Pharm., M. Sc., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Locations

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

Countries

Canada

Other Identifiers

CE12.316

Identifier Type: -

Identifier Source: org_study_id