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

Recruiting

• Conditions: HIV Infections

• Registration Number: NCT05303337
• Lead Sponsor: Hôpital Européen Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Study Start: 2022-04-11
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-25
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• PLWH at a the stable phase of their disease (absence of disease outbreak and absence of treatment modification in the 3 months preceding inclusion),
• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation of the HIV cellular reservoirs at W52 of two switch comparatively to baseline among the 3 groups of PLWH	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Européen Marseille; 🇫🇷 Marseille, France