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| Name | Class |
|---|---|
| National Agency for Research on AIDS and Viral Hepatitis (ANRS) | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Amgen | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| PCSK9 correlation with inflammatory makers/adipocytokines |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Franck Boccara, MD, PhD | Saint Antoine University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department, Saint Antoine University Hospital | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28857822 | Derived | 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. |
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no plan to share IPD
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
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 | Comparisons of PCSK9 levels between controls (HIV-uninfected from blood donors) and HIV-infected patients - from baseline (naive) and after ART initiation. | 1 year |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |