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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)

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ClinicalTrials.gov Identifier: NCT05303337
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Hôpital Européen Marseille

Study Description
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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.


Condition or disease Intervention/treatment
HIV Infections Other: Stool sampling Other: Blood plasma collection

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 11, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients switching towards a long-aging injectable treatment Other: Stool sampling
Stool samples will be collected from participants at baseline and W52

Other: Blood plasma collection
Blood plasma collection to assess persistent inflammation, immune activation and HIV reservoir at baseline,W24,W52
Patients maintaining oral ART 2-drug regimens Other: Stool sampling
Stool samples will be collected from participants at baseline and W52

Other: Blood plasma collection
Blood plasma collection to assess persistent inflammation, immune activation and HIV reservoir at baseline,W24,W52
Patients maintaining oral ART 3 drug regimens Other: Stool sampling
Stool samples will be collected from participants at baseline and W52

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


Outcome Measures
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Primary Outcome Measures :
  1. Variation of the HIV cellular reservoirs at W52 of two switch comparatively to baseline among the 3 groups of PLWH [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Variation of the Shannon index between 0 and 1 year in the different groups of PLWH compared to baseline [ Time Frame: 12 months ]
  2. Variation of the immune profile in participants with an LA-based regimen compared to participants with an oral therapy at W24 and W52 [ Time Frame: 12 months ]
  3. Correlation between the immune profile and the Shannon index at W52 among the different groups of PLWH [ Time Frame: 12 months ]
  4. Correlation between the immune profile and the HIV-reservoirs at W52 among the different groups of PLWH [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People Living with HIV (PLWH)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05303337


Contacts
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Contact: Myriam BENNANI 0413428351 m.bennani@hopital-europeen.fr

Locations
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France
Hôpital Européen Marseille Recruiting
Marseille, France, 13003
Contact: Myriam BENNANI         
Principal Investigator: Christina PSOMAS, Dr         
Sponsors and Collaborators
Hôpital Européen Marseille
More Information
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Responsible Party: Hôpital Européen Marseille
ClinicalTrials.gov Identifier: NCT05303337    
Other Study ID Numbers: 21-40
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes