NCT05303337Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 21 Mar 2022
- Start date
- 11 Apr 2022
- Primary completion date
- Mar 2026
- Lead sponsor
- Hôpital Européen Marseille
- Diseases
- HIV
- NCT number
- NCT05303337
What you commit to
- Study type: Observational
- Planned participants: 120
- From 11 Apr 2022 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two month before stool sampling.
Other
- Subject only coming for full impatient follow-up
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.