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

January 28, 2024 updated by: Franck Boccara
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

193

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Cardiology Department, Saint Antoine University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

HIV-infected patients: 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: adult adult male or female patients.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCSK9 plasma level change after initiation of ART including protease inhibitor boosted with ritonavir (PI/r)
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCSK9 correlation with lipid parameters
Time Frame: 1 year
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
PCSK9 correlation with inflammatory makers/adipocytokines
Time Frame: 1 year
Comparison of inflammatory makers/adipocytokines (IL6, hsCRP, leptin, adiponectin) and PCSK9 change - from baseline (naive) to after ART initiation.
1 year
PCSK9 comparison between HIV-infected and uninfected patients
Time Frame: 1 year
Comparisons of PCSK9 levels between controls (HIV-uninfected from blood donors) and HIV-infected patients - from baseline (naive) and after ART initiation.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franck Boccara

Collaborators

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

Investigators

  • Principal Investigator: Franck Boccara, MD, PhD, Saint Antoine University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

April 29, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPANA - A09 PCSK 9 substudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share IPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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