COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV—Infected Patients
Ключови думи
Резюме
Описание
Background: HIV-infected subjects are at high risk of coronary heart disease (CHD) partly in relation with atherogenic dyslipidemia including increased triglycerides (TG) and LDL-cholesterol (LDL-C). Mechanisms of HIV-associated dyslipidemia are complex, involving HIV itself and some antiretrovirals (ARV), particularly protease inhibitors (PI/r). Elevated proprotein convertase subtilisin kexin 9 (PCSK9) level is associated with increased LDL-C in the general population. How PCSK9 level is regulated in HIV-infected treated patients has never been investigated.
Objectives: We aimed to identify factors associated with circulating PCSK9 concentration in ART-naïve and treated patients and to evaluate the impact of 1st line ARV therapy (ART) comprising a PI/r, on PCSK9 level in HIV-infected patients.
Methods: Fasting plasma concentrations of PCSK9 were measured using ELISA assay in HIV-infected individuals from the ANRS COPANA cohort, at ART initiation and after one year of PI/r-based therapy without any disruption. Subjects not virologically suppressed at follow-up, or taking any lipid lowering therapies at baseline or during follow-up were excluded. Spearman's correlation coefficient was used to determine the association between PCSK9 levels and metabolic parameters at baseline and under PI/r.
Дати
| Последна проверка: | 03/31/2017 |
| Първо изпратено: | 12/25/2016 |
| Очаквано записване подадено: | 04/28/2017 |
| Първо публикувано: | 05/03/2017 |
| Изпратена последна актуализация: | 04/28/2017 |
| Последна актуализация публикувана: | 05/03/2017 |
| Действителна начална дата на проучването: | 02/29/2016 |
| Приблизителна дата на първично завършване: | 08/31/2016 |
| Очаквана дата на завършване на проучването: | 08/31/2016 |
Състояние или заболяване
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| HIV-infected patients HIV-infected adult male or female patients who are HIV treatment naive and initiate antiretroviral therapy including a protease inhibitor during the follow up period. | |
| HIV-uninfected patients HIV-uninfected adult male or female patients. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Метод за вземане на проби | Non-Probability Sample |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Naive HIV-infected male or female > 18 years - Initiation of antiretroviral therapy including a protestase inhibitor during the follow up with blood samples available - Patients controlled at one year with a VL<400 copies/ml Exclusion Criteria: - Subjects under statin or other lipid lowering drugs (fenofibrate, ezetimibe) |
Резултат
Първични изходни мерки
1. PCSK9 plasma level change after initiation of ART including protease inhibitor boosted with ritonavir (PI/r) [1 year]
Вторични изходни мерки
1. PCSK9 correlation with lipid parameters [1 year]
2. PCSK9 correlation with inflammatory makers/adipocytokines [1 year]
3. PCSK9 comparison between HIV-infected and uninfected patients [1 year]
