QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen Clinical Trial
Official 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.
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.
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Observational Model: Cohort, Time Perspective: Prospective