Inflammation in HIV/AIDS-InflammAIDS

NCT07367867 | Completed

• 1 other identifier: ATE220016
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) pandemic still represents a major public health problem with 41 million people currently living with HIV worldwide. Indeed, the advent of antiretroviral therapy (ART) has largely decreased morbidity and mortality associated with HIV/AIDS. Nevertheless, ART is not able to eradicate the virus and, therefore, the management of HIV/AIDS involves a long-term treatment. The persistence of an HIV reservoir is associated with a chronic status of immune activation and inflammation, exacerbating damage in tissues. Consequently, the immunological status of people living with HIV (PLWH) is reminiscent to what is observed in immunosenescence, predisposing them to the development of the so-called non-AIDS defining diseases (NADE), which correspond to conditions commonly observed in aging such as metabolic syndrome, cardiovascular diseases, diabetes, neurocognitive disorders, and non-HIV associated cancers, amongst others. The investigators estimate that more than a half of Chilean patients present metabolic syndrome, a well characterized risk factor including cardiovascular disease , type 2 diabetes and death in the general population but especially in PLWH. The Anillo Inflammation in HIV/AIDS (InflammAIDS) brings together an interdisciplinary group of researchers from life and medical sciences working at public universities and hospitals with the aim of investigating the immune, inflammatory and virological signatures of PLWH with and without metabolic syndrome in Chile and how they influence the clinical outcome of the patients. To accomplish our objectives, the researchers group will first establish a prospective cohort of PLWH, with and without metabolic syndrome, across relevant lifetime periods (childhood, adulthood, and elderly) and will generate the first Chilean collection of samples from the participants of this clinical cohort with Biobank standards, generation standardized and high-quality sample and data collection. These cohorts will be analyzed combining state-of-the-art methodologies such as single-cell RNA sequencing, multiparametric flow cytometry, xMap® Luminex, mass spectrometry and Oxford Nanopore Technologies sequencing together with classical biochemical, molecular, and cellular biology, virological and immunological analyses, determining the immune, inflammatory and virological state associated to the clinical condition of our patients.

Conditions

HIV; Metabolic Syndrome; Molecular Biology; Flow Cytometry; Sequence Analysis; Single Cell Sequencing Technology; Microbiome

Keywords

interdisciplinary group of researchers; PLWH; metabolic syndrome; Chile; HIV; Biobank standards

Outcome Measures

Primary Outcomes (1)

• Characterization of a Chilean cohort of PLWH with and without metabolic syndrome.

  12 month

Secondary Outcomes (19)

• Sociodemographic data questionnaire

  12 months

• Dysbiosis by NGS

  12 months

• Dysbiosis by NGS

  12 months

• Immune cell repertoire by Flow Citometry

  12 months

• Immune cell repertoire by Flow Citometry

  12 months

Study Arms (1)

InflammAIDS cohort is a PLWH cohort with and without metabolic syndrome

The InflammAIDS cohorts is a PLWH cohort from different centers of Santiago and Punta Arenas, including Fundación Arriarán, Hospital Clínico de Magallanes and Hospital del Salvador. These cohorts include men and women, from adolescence to adulthood and senior patients living with HIV under suppressive ART and presenting or not metabolic syndrome. Importantly, the project also have access to a pediatric cohort, including children living with HIV and without metabolic syndrome. A group of HIV negative individuals with and without metabolic syndrome will also be invited to participate to be used as controls when required.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will be obtained from different centers from Santiago and Punta Arenas, including Fundación Arriarán, Hospital Clínico de Magallanes, Hospital del Salvador. These cohorts include men and women, from adolescence to adulthood and senior patients living with HIV under suppressive ART and presenting or not metabolic syndrome. A group of HIV negative individuals with and without metabolic syndrome will also be invited to participate to be used as controls when required.

You may qualify if:

• Adults over 18 years
• Signed informed consent
• HIV diagnosis confirmed by the Public Health Institute
• Patients under clinical control in any of the participating centers
• Availability to attend the taking of samples and medical controls
• Infants and children younger 18 years
• Patients under control in any of the participating center
• Signed informed consent by parents or legal guardians of the minor. In children 8 years and older, also informed assent
• In infants under 4 months of life, HIV diagnosis by a first positive RT-PCR for HIV performed at the Public Health Institute. In infants and children over 4 months, HIV diagnosis is confirmed by the Public Health Institute.
• Children exposed to HIV during pregnancy, labor or breastfeeding of mothers with confirmed HIV, with a negative diagnosis.
• Availability to attend the taking of samples and medical controls, and without medical contraindications for taking the samples (severe anemia according to age).

Sponsors & Collaborators

• Universidad de Magallanes: lead
• University of Chile: collaborator

Study Sites (1)

Centro Asistencial Docente y de Investigación, Universidad de Magallanes

Punta Arenas, Punta Arenas, 6200000, Chile

Location

Related Publications (3)

• Giraldo-Ocampo S, Valiente-Echeverria F, Soto-Rifo R. Host RNA-Binding Proteins as Regulators of HIV-1 Replication. Viruses. 2024 Dec 31;17(1):43. doi: 10.3390/v17010043.

  PMID: 39861832 BACKGROUND

• Acevedo ML, Gaete-Argel A, Alonso-Palomares L, de Oca MM, Bustamante A, Gaggero A, Paredes F, Cortes CP, Pantano S, Martinez-Valdebenito C, Angulo J, Le Corre N, Ferres M, Navarrete MA, Valiente-Echeverria F, Soto-Rifo R. Differential neutralizing antibody responses elicited by CoronaVac and BNT162b2 against SARS-CoV-2 Lambda in Chile. Nat Microbiol. 2022 Apr;7(4):524-529. doi: 10.1038/s41564-022-01092-1. Epub 2022 Apr 1.

  PMID: 35365787 BACKGROUND

• Gonzalez-Puelma J, Aldridge J, Montes de Oca M, Pinto M, Uribe-Paredes R, Fernandez-Goycoolea J, Alvarez-Saravia D, Alvarez H, Encina G, Weitzel T, Munoz R, Olivera-Nappa A, Pantano S, Navarrete MA. Mutation in a SARS-CoV-2 Haplotype from Sub-Antarctic Chile Reveals New Insights into the Spike's Dynamics. Viruses. 2021 May 11;13(5):883. doi: 10.3390/v13050883.

  PMID: 34064904 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1\) Plasma samples: Venous samples will be collected in EDTA-containing tubes. They will be centrifuged for 15 minutes at 1000 g and then fractionated into blood cells and plasma. Plasma will be aliquoted and stored for further processing. 2) Isolation of PBMCs: PBMCs will be obtained from whole blood samples. The untouched PBMCs will be collected into a tube and mixed with cryopreservation medium to avoid cell lysis. Cells will be frozen in liquid nitrogen and transported to be stored until used. 3) Stool samples: A stool sample will be collected. Tubes will be then stored until further processing.

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ricardo Soto-Riffo, PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: January 26, 2026
• Study Start: March 6, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following the data is cleaned, quality checked, and analyzed, the data will be available to the general research community. All data made available for public use will be de-identified data, i.e., stripped of private, protected health information that could be used to deduce the identity of individual subjects, in compliance with the rule.
• Access Criteria: InflammAIDS website will display the data and statistical analysis.

Locations

CL (1)