Influence of the composition of the intestinal microbiome on the progression of arteriosclerosis in patients with HIV infection in effective antiretroviral treatment (Q3144649): Difference between revisions
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(Created claim: summary (P836): Objectives: Evaluate the relationship between the composition of the intestinal microbiome and the progression of arteriosclerosis in patients infected with HIV virologically suppressed with antiretroviral therapy (ART) Method: Prospective longitudinal study with a follow-up of 2 years. Consecutive patients in RA and virologically suppressed for at least 6 months with a regimen based on non-nucleoside reverse transcriptase inhibitors or integras...) |
(Changed label, description and/or aliases in en: translated_label) |
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Influence of the composition of the intestinal microbiome on the progression of arteriosclerosis in patients with HIV infection in effective antiretroviral treatment | |||
Revision as of 14:08, 12 October 2021
Project Q3144649 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Influence of the composition of the intestinal microbiome on the progression of arteriosclerosis in patients with HIV infection in effective antiretroviral treatment |
Project Q3144649 in Spain |
Statements
30,750.0 Euro
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61,500.0 Euro
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50.0 percent
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1 January 2017
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31 March 2020
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FUNDACION PARA EL FOMENTO DE LA INV. SANITARIA Y BIOMEDICA DE LA COMUNIDAD VALENCIANA (FISABIO)
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38°15'55.19"N, 0°41'55.82"W
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03065
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Objetivos: Evaluar la relación entre la composición del microbioma intestinal y la progresión de la arteriosclerosis en pacientes infectados por el VIH virológicamente suprimidos con tratamiento antirretroviral (TAR) Método: Estudio longitudinal prospectivo con un seguimiento de 2 años. Se incluirán pacientes consecutivos en TAR y virológicamente suprimidos durante, al menos, 6 meses con una pauta basada en inhibidores de la transcriptasa inversa no análogos de nucleósidos o inhibidores de la integrasa. Se medirán el grosor íntima-media carotídeo (GIMc) y la vasodilatación dependiente del endotelio (VDE) a nivel braquial con ecografía de alta resolución. Se recogerán muestras de heces para el estudio de la composición de la microbiota, que se clasificará en categorías en relación a la diversidad y patrón predominante. Se medirán las concentraciones de diferentes biomarcadores inflamatorios, de activación inmune, translocación bacteriana y metabolitos pro-aterogénicos derivados del metabolismo bacteriano intestinal. Los procedimientos del estudio se realizarán en la visita basal y a los 12 y 24 meses. El criterio principal de valoración será el cambio en el GIMc a los 24 meses. Se estima incluir 208 pacientes para una potencia del 90% para detectar diferencias de al menos 0.09 mm en la medida del GIMc entre dos categorías de composición de la microbiota, con un error alfa bilateral del 5% y asumiendo una distribución del GIMc de media 0.7 mm y desviación estándar de 0.2 mm. (Spanish)
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Objectives: Evaluate the relationship between the composition of the intestinal microbiome and the progression of arteriosclerosis in patients infected with HIV virologically suppressed with antiretroviral therapy (ART) Method: Prospective longitudinal study with a follow-up of 2 years. Consecutive patients in RA and virologically suppressed for at least 6 months with a regimen based on non-nucleoside reverse transcriptase inhibitors or integrase inhibitors shall be included. Intra-media carotid thickness (CIM) and endothelium-dependent vasodilation (VDE) at the brachial level with high-resolution ultrasound shall be measured. Stool samples shall be collected for the study of the composition of the microbiota, which shall be classified into categories in relation to the diversity and predominant pattern. The concentrations of different inflammatory biomarkers, immune activation, bacterial translocation and pro-atherogenic metabolites derived from intestinal bacterial metabolism shall be measured. The study procedures will be performed during the baseline visit and at 12 and 24 months. The main endpoint will be the change in CIM at 24 months. It is estimated to include 208 patients for a 90 % potency to detect differences of at least 0.09 mm in the measurement of the cIM between two categories of microbiota composition, with a bilateral alpha error of 5 % and assuming a distribution of the CIM of mean 0.7 mm and standard deviation of 0.2 mm. (English)
12 October 2021
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Elche/Elx
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Identifiers
PI16_01740
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