Evolution of the Clinical, Immuno-virological and Aging Trajectory of Patients Living With HIV

NCT06258122 | Recruiting

• 1 other identifier: CREPATS 17
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective is:

• To characterize the evolution of the immuno-virological profile of circulating blood cells and immune aging in patients who had participated to TEMPO-1 in 2007-2008
• To evaluate the role of immune aging and inflammatory profile in the occurrence of comorbidities in HIV-infected individuals over a 15-year period The alterations that affect the innate and adaptive immune cell compartments in HIV-infected patients are reminiscent of the process of immune aging, characteristic of old age. These alterations, the presumed cause of which is the chronic systemic immune activation established in patients, contribute to the depletion of lymphoid resources which probably leads to the decline of immune competence with the progression of HIV disease. The comparison between HIV-1-infected patients and uninfected older adults goes beyond the mere appearance of immunosenescence and extends to the deterioration of a number of physiological functions linked to inflammation and to systemic aging. By inducing persistent and lasting immune activation, HIV-1 infection is now considered a model of accelerated immunosenescence and systemic aging. During this process, the immune system quickly becomes exhausted, because the source of its exhaustion (i.e. HIV) cannot be eliminated. To determine which factors may contribute to immunosenescence in HIV-1 infection, we propose an extensive immune and virological evaluation in patients who participated in a cross-sectional assessment of immune functions and TEMPO-1 viral reservoirs after 15 years of evolution in order to determine their immune and viral trajectories, to compare these trajectories with the major clinical events and the comorbidities occurring in them.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• measure of number of participants with the frequency of circulating leukocyte cells

  Assessment of 32 biomarkers by Cytek Aurora cytometry to identify more than 15 populations of immune cells

  one year

• measureof number of participants with the number of hematopoietic stem cells in peripheral blood and their ability to develop a myeloid or lymphoid lineage in culture

  Assessment by culture

  one year

Secondary Outcomes (3)

• measure of number of participants with cytokines and chemokines, being associated with the appearance of comorbidities

  one year

• Measure of number of participants with Microbial translocation markers

  one year

• Measure of number of participants with the HIV viral reservoir (DNA)

  one year

Eligibility Criteria

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

Study Population

HIV-infected individuals and non-HIV infected control group

You may qualify if:

• Previous participation to the TEMPO-1 study
• years of age or older
• HIV-infected individuals and non-HIV infected control group
• Be affiliated or beneficiary of a social security scheme
• Have signed the consent form.

You may not qualify if:

• Subject under " sauvegarde de justice " (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

HIV Infections

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

Central Study Contacts

Yasmine DUDOIT

CONTACT

+33142164181; yasmine.dudoit@aphp.fr

Delphine SAUCE

CONTACT

+33140779889; delphine.sauce@sorbonne-universitec.fr

Study Design

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

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: April 23, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

FR (1)