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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01824628
First received: April 2, 2013
Last updated: November 25, 2013
Last verified: November 2013

April 2, 2013
November 25, 2013
March 2013
October 2013   (final data collection date for primary outcome measure)
QT and corrected QT (QTc) intervals determined by a 12-leads ECG [ Time Frame: Day 0 = Day 1 - This is a transversal study. ] [ Designated as safety issue: No ]

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.

QT and corrected QT (QTc) intervals determined by a 12-leads ECG [ Time Frame: Day 0 = Day 1 - This is a transversal study. ] [ Designated as safety issue: No ]

The QT/QTc intervals are determined by a 100mm/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.

Complete list of historical versions of study NCT01824628 on ClinicalTrials.gov Archive Site
  • Prevalence of QTc interval prolongation in both study groups [ Time Frame: Day 0 = Day 1 - This is a transversal study. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Comparison of the QT/QTc Interval Between an Outpatient HIV-Infected Population on Antiretroviral Therapy and Two Large HIV-Negative Cohorts
Comparaison Des Intervalles QT/QTc Entre Une Population HIV Positive Ambulatoire Sous thérapie antirétrovirale et Une Population Ambulatoire HIV négative

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

10 mL whole blood in a purple Vacutainer EDTA tube

Non-Probability Sample

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.

QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen
Not Provided
  • • HIV positive subjects receiving antiretroviral regimen
  • • HIV negative subjects from the pre-admission surgical clinic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
November 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01824628
CE12.316
No
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Not Provided
Principal Investigator: Jacques Turgeon, B. Pharm., M. Sc., Ph. D. Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP