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

NCT ID: NCT05303337

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2026-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients switching towards a long-aging injectable treatment

Stool sampling

Intervention Type: OTHER

Stool samples will be collected from participants at baseline and W52

Blood plasma collection

Intervention Type: OTHER

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

Patients maintaining oral ART 2-drug regimens

Stool sampling

Intervention Type: OTHER

Stool samples will be collected from participants at baseline and W52

Blood plasma collection

Intervention Type: OTHER

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

Patients maintaining oral ART 3 drug regimens

Stool sampling

Intervention Type: OTHER

Stool samples will be collected from participants at baseline and W52

Blood plasma collection

Intervention Type: OTHER

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

Interventions

Stool sampling

Stool samples will be collected from participants at baseline and W52

Intervention Type: OTHER

Blood plasma collection

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Européen Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Myriam BENNANI

Role: CONTACT

m.bennani@hopital-europeen.fr

0413428351

Facility Contacts

Myriam BENNANI

Role: primary

Other Identifiers

21-40

Identifier Type: -

Identifier Source: org_study_id