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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients switching towards a long-aging injectable treatment |
| ||
| Patients maintaining oral ART 2-drug regimens |
| ||
| Patients maintaining oral ART 3 drug regimens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool sampling | Other | Stool samples will be collected from participants at baseline and W52 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the HIV cellular reservoirs at W52 of two switch comparatively to baseline among the 3 groups of PLWH | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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People Living with HIV (PLWH)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myriam BENNANI | Contact | 0413428351 | m.bennani@hopital-europeen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Marseille | Recruiting | Marseille | 13003 | France |
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| Blood plasma collection | Other | Blood plasma collection to assess persistent inflammation, immune activation and HIV reservoir at baseline,W24,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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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