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

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

This project will try to see if switching people living with HIV who are virologically suppressed to long-acting injectable therapy changes their immune activation, HIV reservoir, or gut microbiome compared with those who remain on oral integrase-based regimens.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hôpital Européen Marseille (Academic / other)
• Locations: 1 site (Marseille)
• Trial ID: NCT05303337 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults living with HIV who are virologically suppressed for at least one year, clinically stable with no recent treatment changes, have a CD4+ nadir >200/mm3, attend outpatient follow-up at the center, and can give informed consent.

Not a fit: Patients who recently used antibiotics, probiotics, or other microbiota-altering treatments, those with recent treatment changes or virological instability, or those only seen as inpatients are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, the study could clarify whether long-acting injectable therapy reduces inflammation or alters the HIV reservoir or gut microbiome, helping clinicians choose treatments that may lower long-term non-AIDS comorbidity risk.

How similar studies have performed: Previous work has described inflammation, microbial translocation, and dysbiosis in treated HIV, but there is currently no clear evidence showing a differential impact on inflammation, reservoirs, or microbiota between long-acting injectable and oral integrase-based regimens, so this comparison is relatively novel.

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

Where this trial is running

Marseille

• Hôpital Européen Marseille — Marseille, France (Recruiting)

Study contacts

• Study coordinator: Myriam BENNANI

Conditions HIV Infections