Immune Activation as a Cause of Insulin Resistance in Adults Living With HIV-1 on Effective Antiretroviral Therapy

NCT04028882 | Terminated

• 1 other identifier: RECHMPL18_0373
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to characterize in non-viremic HIV-1 patients under antiretroviral therapy an immune activation profile that the investigators have previously shown to be strongly linked to hyperinsulinemia. This characterization will be carried out via 3 different approaches. First, the investigators will analyze the metabolites present in the plasma of patients presenting with the profile of interest. Second, the investigators will study the transcriptome of the peripheral blood mononuclear cells of these patients. Finally, the investigators will search whether some factors released by these cells are able to induce insulin resistance. In addition the ability of the profile of interest to predict an increase in insulinemia over time will be assessed.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• Metabolomic analysis on plasma and PBMC

  The investigators will analyze by mass spectrometry the metabolites present in the plasma of patients presenting with the profile of interest as compared with patients with other immune activation profiles. Metabolites will be extracted from the blood plasma using a salt assisted liquid-liquid extraction. The metabolites will then be allowed to crystallize on the metallic surface. Finally, the plate content will be analyzed by desorption electrospray ionisation mass spectrometry using positive and negative ionization.

  18 months

• Transcriptomic analysis on plasma and PBMC

  The investigators will also analyze by RNASeq the messenger RNA (mRNA) produced by the PBMC of patients presenting with the profile of interest and compared them with the mRNA produced by the PBMC of patients with other immune activation profiles.

  18 months

Secondary Outcomes (2)

• Follow-up over time of insulinemia in patients with various immune activation profiles

  18 months

• Test whether PBMC from patients with Profile#2 induce insulin resistance

  18 months

Study Arms (1)

Non viremic HIV patients under treatment

Patients with various immune activation profiles

Other: Signaling, metabolomic and transcriptomic analysis

Interventions

Signaling, metabolomic and transcriptomic analysis OTHER

Signaling, metabolomic and transcriptomic analysis

Non viremic HIV patients under treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-1-infected adults under efficient antiretroviral therapy

You may qualify if:

• Subject consulting or hospitalized in the tropical and infectious diseases unit at the University Hospital of Montpellier that have been enrolled in a study during which the immune activation profile was analyzed
• Subject aged at least 18 years
• Subject speaking french fluently
• Subject who is not opposed to participate to the study, after a clear information
• Subject affiliated to a social security system
• Infection by HIV-1 determined by a positive serology or by a measure of the plasma viral load (RNA HIV)
• HIV-1 patients under stable antiretroviral therapy
• HIV load \< 50 copies/mL since at least 6 months before enrollment (2 measures)

You may not qualify if:

• Vulnerable individuals
• Persons protected
• Pregnant women or breastfeeding mothers
• Bad understanding of the nature and goals of the study and/or communication difficulties with the investigator
• Non infectious pathology that might be the origin of an immune anomaly
• Treatment by an immune modulator molecule or by chemotherapy in the 60 days before enrollment in the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Saint Eloi Hospital, University Hospital of Montpellier

Montpellier, Hérault, 34295, France

Location

Related Publications (2)

• Psomas C, Younas M, Reynes C, Cezar R, Portales P, Tuaillon E, Guigues A, Merle C, Atoui N, Fernandez C, Le Moing V, Barbuat C, Marin G, Nagot N, Sotto A, Eliaou JF, Sabatier R, Reynes J, Corbeau P. One of the immune activation profiles observed in HIV-1-infected adults with suppressed viremia is linked to metabolic syndrome: The ACTIVIH study. EBioMedicine. 2016 Jun;8:265-276. doi: 10.1016/j.ebiom.2016.05.008. Epub 2016 May 10.

  PMID: 27428436 BACKGROUND

• Younas M, Gimenez S, Lin YL, Mettling C, Maiorano D, Reynes J, Pasero P, Rondard P, Psomas CK, Corbeau P. gamma-Aminobutyric Acid-Induced Monocytic Reactive Oxygen Species Impair CD4 Restoration in Treated Adults With HIV-1. J Infect Dis. 2025 Jun 2;231(5):1246-1257. doi: 10.1093/infdis/jiaf058.

  PMID: 39903648 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and peripheral blood mononuclear cells (PBMC)

MeSH Terms

Conditions

HIV Infections

Interventions

Signal Transduction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biochemical Phenomena; Chemical Phenomena; Cell Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: July 23, 2019
• Study Start: March 3, 2020
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)