COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients

Dyslipidemias Clinical Trial

— COPANA  

Official title:

COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139630
• Other study ID #: COPANA - A09 PCSK 9 substudy
• Status: Completed
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: January 2024
• Source: Saint Antoine University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dyslipidemias
• HIV Seropositivity
• PCSK9

Locations

Country	Name	City	State
France	Cardiology Department, Saint Antoine University Hospital	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Franck Boccara	Amgen, Institut National de la Santé Et de la Recherche Médicale, France, National Agency for Research on AIDS and Viral Hepatitis (ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCSK9 plasma level change after initiation of ART including protease inhibitor boosted with ritonavir (PI/r)	Mean percent change in PCSK9 plasma levels after initiation of ART including protease inhibitor boosted with ritonavir (PI/r)r in naïve HIV-infected patients: comparison of values at ART initiation.	1 year
Secondary	PCSK9 correlation with lipid parameters	Correlations between PCSK9 levels under PI/r and lipid parameters (LDLc, HDLc, triglycerides) and other parameters (glycemia, HOMA_IR) - from baseline to end.	1 year
Secondary	PCSK9 correlation with inflammatory makers/adipocytokines	Comparison of inflammatory makers/adipocytokines (IL6, hsCRP, leptin, adiponectin) and PCSK9 change - from baseline (naive) to after ART initiation.	1 year
Secondary	PCSK9 comparison between HIV-infected and uninfected patients	Comparisons of PCSK9 levels between controls (HIV-uninfected from blood donors) and HIV-infected patients - from baseline (naive) and after ART initiation.	1 year