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
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparaison Des Intervalles QT/QTc Entre Une Population HIV Positive Ambulatoire Sous thérapie antirétrovirale et Une Population Ambulatoire HIV négative

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

10 mL whole blood in a purple Vacutainer EDTA tube


Enrollment: 160
Study Start Date: March 2013
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
• HIV positive subjects receiving antiretroviral regimen
• HIV negative subjects from the pre-admission surgical clinic

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824628

Locations
Canada, Quebec
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
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Jacques Turgeon, B. Pharm., M. Sc., Ph. D. Centre de Recherche du Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01824628     History of Changes
Other Study ID Numbers: CE12.316
Study First Received: April 2, 2013
Last Updated: November 25, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014