Changes in HIV reservoir, inflammation, and gut microbiome after switching to long-acting injectable versus staying on oral integrase-based therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational comparison of people living with HIV who switch to long-acting injectable antiretroviral therapy versus those who remain on oral dual or triple integrase-based regimens. Participants must be virologically suppressed (≤50 copies/mL for at least one year), clinically stable, and have a CD4+ nadir >200/mm3; stool and blood plasma samples will be collected. The study will analyze markers of inflammation, microbial translocation, HIV reservoir size, and the composition of the gut microbiota to characterize differences between groups. Antibiotic or probiotic use within two months of stool sampling is excluded because it can disrupt the microbiota signal.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Européen Marseille
  Marseille, France Recruiting

Study contacts

• Study coordinator: Myriam BENNANI
• Email: m.bennani@hopital-europeen.fr
• Phone: 0413428351

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.