Evolution of HIV Reservoir, Inflammation and Microbiota Footprint of PLWH Switching to Long-acting Injectable Treatment Compared to Patients on Oral Dual or Triple Anti-integrase-based Therapy

NCT05303337 | Recruiting

• 1 other identifier: 21-40
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In the last 40 years of HIV history, we have managed to attain most of our therapeutic objectives, namely virological suppression of most patients and sufficient immune reconstitution. Still, immune activation and inflammation persist and even if they decrease on ART (AntiRetroviral Treatment), they do not disappear and may be associated to multiple non-AIDS related comorbidities. In this population structural and functional modifications of GALT (Gut Associated Lymphoïd Tissue) are observed early after HIV infection and persist despite virological suppression on ART. Moreover, imbalance of the gut microbiota which is called dysbiosis may participate in persistent activation and therefore enhancement of residual HIV viral replication. GALT modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis. Up to now, there is no evidence of a differential impact on inflammation, immune activation or cellular reservoirs of different ART regimens. Long-Acting (LA) regimens could theoretically display better inflammatory profile, since they have a better tissue distribution and could act more efficiently on HIV reservoirs. On the other hand, LA's direct administration shunting the gut passage could also contribute to less gut dysbiosis. The objective of our study is to assess impact on plasma biomarkers, cell-surface biomarkers, intestinal microbiota and cellular reservoirs of a switch from an oral dual or triple anti-integrase-based therapy ART regimen including an anti-integrase compared to a Long-Acting (LA) injectable treatment.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Variation of the HIV cellular reservoirs at W52 of two switch comparatively to baseline among the 3 groups of PLWH

  12 months

Secondary Outcomes (4)

• Variation of the Shannon index between 0 and 1 year in the different groups of PLWH compared to baseline

  12 months

• Variation of the immune profile in participants with an LA-based regimen compared to participants with an oral therapy at W24 and W52

  12 months

• Correlation between the immune profile and the Shannon index at W52 among the different groups of PLWH

  12 months

• Correlation between the immune profile and the HIV-reservoirs at W52 among the different groups of PLWH

  12 months

Study Arms (3)

Patients switching towards a long-aging injectable treatment

Other: Stool sampling; Other: Blood plasma collection

Patients maintaining oral ART 2-drug regimens

Other: Stool sampling; Other: Blood plasma collection

Patients maintaining oral ART 3 drug regimens

Other: Stool sampling; Other: Blood plasma collection

Interventions

Stool sampling OTHER

Stool samples will be collected from participants at baseline and W52

Patients maintaining oral ART 2-drug regimens; Patients maintaining oral ART 3 drug regimens; Patients switching towards a long-aging injectable treatment

Blood plasma collection OTHER

Blood plasma collection to assess persistent inflammation, immune activation and HIV reservoir at baseline,W24,W52

Patients maintaining oral ART 2-drug regimens; Patients maintaining oral ART 3 drug regimens; Patients switching towards a long-aging injectable 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

People Living with HIV (PLWH)

You may qualify if:

• Subject with ongoing HIV follow-up on an outpatient basis (outpatient or day hospital consultation) in the participating center, and having virological suppression at the threshold of 50 copies / mL for at least 1 year (blips \< 200 copies / mL tolerated during this period)
• CD4 + T cell nadir\> 200 / mm3
• Having given free and informed written consent
• Being affiliated with or benefiting from a social security scheme.

You may not qualify if:

• Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two month before stool sampling.
• Subject only coming for full impatient follow-up

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

Hôpital Européen Marseille

Marseille, 13003, 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

Myriam BENNANI

CONTACT

0413428351; m.bennani@hopital-europeen.fr

Study Design

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

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: April 11, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

FR (1)