QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen Clinical Trial
— QTVIEOfficial title:
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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | November 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | Unité Hospitalière de Recherche et d'Enseignement et de Soins sur le Sida (UHRESS) ; Centre Hospitalier de l'Université de Montréal (CHUM) | Montréal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | QT and corrected QT (QTc) intervals determined by a 12-leads ECG | 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. |
Day 0 = Day 1 - This is a transversal study. | No |
| Secondary | Prevalence of QTc interval prolongation in both study groups | 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. | Day 0 = Day 1 - This is a transversal study. | No |
| Secondary | To assess risk factors of QTc interval prolongation in both study groups | 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. | Day 0 = Day 1 - This is a transversal study. | No |
| Secondary | Prevalence of QT/QTc intervals prolongation and associated risk factors among outpatient HIV subjects | 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. | Day 0 = Day 1 - This is a transversal study. | No |
| Secondary | Evaluate the influence of genetic polymorphisms on PI's pharmacokinetic metabolisms in outpatient HIV positive subjects treated with a PI | 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. | Day 0 = Day 1 - This is a transversal study | No |