HIV InfectionsLAMIVIHNCT05303337
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
An observational study of HIV Infections, run by Hôpital Européen Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Stool sampling and Blood plasma collection
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2022to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People Living with HIV (PLWH)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Européen Marseille
Marseille, 13003
Myriam BENNANI
Christina PSOMAS, Dr
About this study
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
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.
Read more
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.
- Conditions
- HIV Infections
- Being tested
- Stool sampling, Blood plasma collection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplingOther
Stool samples will be collected from participants at baseline and W52
Blood plasma collectionOther
Blood plasma collection to assess persistent inflammation, immune activation and HIV reservoir at baseline,W24,W52
| Study group | Role | What they receive |
|---|---|---|
| Patients switching towards a long-aging injectable treatment | Not described Receives: Other: Stool sampling; Other: Blood plasma collection | |
| Patients maintaining oral ART 2-drug regimens | Not described Receives: Other: Stool sampling; Other: Blood plasma collection | |
| Patients maintaining oral ART 3 drug regimens | Not described Receives: Other: Stool sampling; Other: Blood plasma collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the HIV cellular reservoirs at W52 of two switch comparatively to baseline among the 3 groups of PLWH
Measured: 12 months
Secondary outcomes (4)
Variation of the Shannon index between 0 and 1 year in the different groups of PLWH compared to baseline
Measured: 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
Measured: 12 months
Correlation between the immune profile and the Shannon index at W52 among the different groups of PLWH
Measured: 12 months
Correlation between the immune profile and the HIV-reservoirs at W52 among the different groups of PLWH
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start11 Apr 2022
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303337
- Sponsor's protocol ID
- 21-40
- Acronym
- LAMIVIH
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05303337
- Acronym / sponsor ID
- LAMIVIH / 21-40
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients switching towards a long-aging injectable treatment | – | Other: Stool sampling, Other: Blood plasma collection |
| Patients maintaining oral ART 2-drug regimens | – | Other: Stool sampling, Other: Blood plasma collection |
| Patients maintaining oral ART 3 drug regimens | – | Other: Stool sampling, Other: Blood plasma collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People Living with HIV (PLWH)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool samplingStool samples will be collected from participants at baseline and W52 | Other | Patients maintaining oral ART 2-drug regimens, Patients maintaining oral ART 3 drug regimens, Patients switching towards a long-aging injectable treatment |
| Blood plasma collectionBlood plasma collection to assess persistent inflammation, immune activation and HIV reservoir at baseline,W24,W52 | Other | Patients maintaining oral ART 2-drug regimens, Patients maintaining oral ART 3 drug regimens, Patients switching towards a long-aging injectable treatment |
Primary outcome
Variation of the HIV cellular reservoirs at W52 of two switch comparatively to baseline among the 3 groups of PLWH
Time frame: 12 months
4 secondary outcomes
Variation of the Shannon index between 0 and 1 year in the different groups of PLWH compared to baseline
Time frame: 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
Time frame: 12 months
Correlation between the immune profile and the Shannon index at W52 among the different groups of PLWH
Time frame: 12 months
Correlation between the immune profile and the HIV-reservoirs at W52 among the different groups of PLWH
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Hôpital Européen Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myriam BENNANI (0413428351, m.bennani@hopital-europeen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the HIV cellular reservoirs at W52 of two switch comparatively to baseline among the 3 groups of PLWH (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.