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

NCT03139630 | Completed

• 1 other identifier: COPANA - A09 PCSK 9 substudy
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Seropositivity; Dyslipidemias; PCSK9

Keywords

HIV, Dyslipidemia; Dyslipidemia; Protease Inhibitor; Ritonavir; PCSK9; Observational

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PCSK9 correlation with lipid parameters

  1 year

• PCSK9 correlation with inflammatory makers/adipocytokines

  1 year

• PCSK9 comparison between HIV-infected and uninfected patients

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Subjects under statin or other lipid lowering drugs (fenofibrate, ezetimibe)

Sponsors & Collaborators

• Franck Boccara: lead
• National Agency for Research on AIDS and Viral Hepatitis (ANRS): collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Amgen: collaborator

Study Sites (1)

Cardiology Department, Saint Antoine University Hospital

Paris, 75012, France

Location

Related Publications (1)

• Boccara F, Ghislain M, Meyer L, Goujard C, Le May C, Vigouroux C, Bastard JP, Fellahi S, Capeau J, Cohen A, Cariou B; ANRS-COPANA Study Group. Impact of protease inhibitors on circulating PCSK9 levels in HIV-infected antiretroviral-naive patients from an ongoing prospective cohort. AIDS. 2017 Nov 13;31(17):2367-2376. doi: 10.1097/QAD.0000000000001633.

  PMID: 28857822 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples taken from the Biobank stored at Tenon Hospital, Paris (Biochemistry department). ELISA Cyclex. Plasma PCSK9 concentrations assayed in triplicates using a quantitative sandwich ELISA assay and following the manufacturer instructions (Circulex CY-8079, CycLex Co, Nagano, Japan). The ELISA kit relies on a quantitative sandwich enzyme immunoassay technique with inter- and intraplate CVs of 2.9-7.3% and 1.5-2.6%, respectively.

MeSH Terms

Conditions

HIV Seropositivity; Dyslipidemias

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Franck Boccara, MD, PhD

  Saint Antoine University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Senior Cardiologist, Deputy Director of the Division of Cardiology

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: May 4, 2017
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)