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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 — LAMIVIH  

HIV Infections Clinical Trial

Official title:
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: a Prospective Longitudinal Comparative Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05303337
Study type Observational
Source Hôpital Européen Marseille
Contact Myriam BENNANI
Phone 0413428351
Email m.bennani@hopital-europeen.fr
Status Recruiting
Phase
Start date April 11, 2022
Completion date March 2024
View Details
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