HIV-1 InfectionGALTNCT02906137
Gut-Associated Lymphocyte Trafficking
A study testing Peripheral blood and intestinal biopsies will be collected in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 2 sites in France.
Trial summary
The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the gut lumen into the bloodstream that fuels deleterious systemic inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Peripheral blood and intestinal biopsies will be collected
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Feb 2017to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For HIV-1-infected subjects group :
- Age at least 18-year old
- HIV-1 infection
- Receiving continuous cART for ≥ 12 months, started during the chronic phase
- Plasma viral load ≤50 copies/mL for ≥ 6 months (one blip ≤200 copies/mL authorized)
- Blood CD4+ T cells count ≥ 350 cells/mm3
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- Indication for upper and/or lower digestive endoscopy
- Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme)
- Written informed consent.
- For uninfected control group :
- Age at least 18-year old
- Indication for upper and/or lower digestive endoscopy
- Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme)
- Written informed consent
Who cannot join
- For HIV-1-infected subject group :
- HIV-2 infection
- Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) ; coeliac disease
- Platelets count <50 G/L or abnormal hemostasis tests
- Decompensated cirrhosis
- Past or current lymphoma
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- Involvement in an HIV-1 immunotherapeutic vaccine study
- Pregnant or breastfeeding women
- Subjects participating in a study excluding participating in another study
- Vulnerability, such as an age under 18, tutorship, trusteeship, or subjects deprived of liberty by a legal or administrative decision.
- For uninfected control group :
- HIV-1 and 2 infection
- Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) ; coeliac disease
- Platelets count <50 G/L or abnormal hemostasis tests
- Decompensated cirrhosis
- Past or current lymphoma
- Pregnant or breastfeeding women
- Subjects participating in a study excluding participating in another study
- Vulnerability, such as an age under 18, tutorship, trusteeship, or subjects deprived of liberty by a legal or administrative decision
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Purpan - Service de Médecine Interne
Toulouse, 31059
Hôpital Purpan - Service des maladies Infectieuses
Toulouse, 31059
About this study
Official title: Altered Homing of T Lymphocytes to the Gut and Poor Immune Reconstitution of the Intestinal Mucosa in Treated HIV-infected Individuals
The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the gut lumen into the bloodstream that fuels deleterious systemic inflammation. The chemotaxis axes that allow T lymphocytes to migrate from the blood to the gut mucosa in order to reconstitute the mucosal immune barrier seems altered in treated HIV-1-infected subjects.This study aims at better understanding the mechanisms involved in this lack of mucosal immune restoration.
Read the detailed description
Pathophysiological study in human subjects, comparative, national, multicentric and prospective. Peripheral blood and intestinal biopsies will be collected.
- Conditions
- HIV-1 Infection
- Being tested
- Peripheral blood and intestinal biopsies will be collected
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood and intestinal biopsies will be collectedOther
Blood draw and intestinal biopsies
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 infected subjects | Experimental | 40 subjects will be recruited in the Department of Infectious Diseases of Toulouse University Hospital, France:
* 15 subjects will have an upper endoscopy (gastroscopy) with duodenal sampling
* 15 subjects will have a lower endoscopy (coloscopy) with colonic and ileal sampling
* 10 subjects will have both a gastroscopy and a coloscopy Receives: Other: Peripheral blood and intestinal biopsies will be collected |
| Uninfected-controls | Other | 40 subjects will be recruited in the Department of Internal Medicine of Toulouse University Hospital, France:
* 10 subjects will have an upper endoscopy (gastroscopy) with duodenal sampling
* 10 subjects will have a lower endoscopy (coloscopy) with colonic and ileal sampling
* 20 subjects will have both a gastroscopy and a coloscopy Receives: Other: Peripheral blood and intestinal biopsies will be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune status: Measure of the frequencies of Th1 in peripheral blood and gut mucosa.
The frequencies of Th1 will be measured by flow cytometry.
Measured: Baseline
Immune status: Measure of the frequencies of Th17 in peripheral blood and gut mucosa.
The frequencies of Th17 will be measured by flow cytometry.
Measured: Baseline
Immune status: Measure of the frequencies of Th22 in peripheral blood and gut mucosa.
The frequencies of Th22 will be measured by flow cytometry.
Measured: Baseline
Secondary outcomes (9)
Immune status: Quantification of cytokines in blood and gut mucosa.
The quantification of cytokines will be measured by luminex.
Measured: Baseline
Immune status: Quantification of cytokines in blood and gut mucosa.
The quantification of cytokines will be measured by immuno-histochemistry.
Measured: Baseline
Immune status: Quantification of chemiokines in blood and gut mucosa.
The quantification of chemiokines will be measured by luminex.
Measured: Baseline
Immune status: Quantification of chemiokines in blood and gut mucosa.
The quantification of chemiokines will be measured by immuno-histochemistry.
Measured: Baseline
Microbial translocation : Quantification of soluble CD14 in plasma.
The quantification of CD 14 will be realised by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Baseline
Microbial translocation : Quantification of soluble soluble CD163 in plasma.
The quantification of CD163 will be realised by Enzyme-Linked Immunosorbent Assay (ELISA) .
Measured: Baseline
Microbial translocation : Quantification of Lipopolysaccharide Binding Protein (LBP).
The quantification of Lipopolysaccharide Binding Protein will be realised by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Baseline
Microbial translocation : Quantification of Intestinal-type Fatty Acid-Binding Protein (I-FABP) in plasma.
The quantification of Intestinal-type Fatty Acid-Binding Protein (I-FABP) will be realised by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Baseline
Microbial translocation : Quantification of 16S RNA.
The quantification of 16S RNA will be realised by real-time Polymerase Chaine Reaction (qPCR).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start6 Feb 2017
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906137
- Sponsor's protocol ID
- ANRS EP61 GALT
- Acronym
- GALT
- Status last verified
- Apr 2026
- First submitted
- 17 Aug 2016
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nayrac M, Requena M, Loiseau C, Cazabat M, Suc B, Carrere N, Barange K, Alric L, Martin-Blondel G, Izopet J, Delobel P. Th22 cells are efficiently recruited in the gut by CCL28 as an alternative to CCL20 but do not compensate for the loss of Th17 cells in treated HIV-1-infected individuals. Mucosal Immunol. 2021 Jan;14(1):219-228. doi: 10.1038/s41385-020-0286-6. Epub 2020 Apr 28.
PubMed 32346082Collercandy N, Vellas C, Nayrac M, Requena M, Richarme T, Iscache AL, Latour J, Barange K, Alric L, Martin-Blondel G, Serino M, Izopet J, Delobel P. Cytotoxic CX3CR1+ Vdelta1 T cells clonally expand in an interplay of CMV, microbiota, and HIV-1 persistence in people on antiretroviral therapy. PLoS Pathog. 2025 Sep 8;21(9):e1013489. doi: 10.1371/journal.ppat.1013489. eCollection 2025 Sep.
PubMed 40920867
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Homing of T Lymphocytes to the Gut and Poor Immune Reconstitution of the Intestinal Mucosa in Treated HIV-infected Individuals
- ClinicalTrials.gov ID
- NCT02906137
- Acronym / sponsor ID
- GALT / ANRS EP61 GALT
- Conditions
- HIV-1 Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the gut lumen into the bloodstream that fuels deleterious systemic inflammation. The chemotaxis axes that allow T lymphocytes to migrate from the blood to the gut mucosa in order to reconstitute the mucosal immune barrier seems altered in treated HIV-1-infected subjects.This study aims at better understanding the mechanisms involved in this lack of mucosal immune restoration.
Detailed description
Pathophysiological study in human subjects, comparative, national, multicentric and prospective. Peripheral blood and intestinal biopsies will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-1 infected subjects | Experimental | Other: Peripheral blood and intestinal biopsies will be collected40 subjects will be recruited in the Department of Infectious Diseases of Toulouse University Hospital, France: * 15 subjects will have an upper endoscopy (gastroscopy) with duodenal sampling * 15 subjects will have a lower endoscopy (coloscopy) with colonic and ileal sampling * 10 subjects will have both a gastroscopy and a coloscopy |
| Uninfected-controls | Other | Other: Peripheral blood and intestinal biopsies will be collected40 subjects will be recruited in the Department of Internal Medicine of Toulouse University Hospital, France: * 10 subjects will have an upper endoscopy (gastroscopy) with duodenal sampling * 10 subjects will have a lower endoscopy (coloscopy) with colonic and ileal sampling * 20 subjects will have both a gastroscopy and a coloscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age at least 18-year old
- HIV-1 infection
- Receiving continuous cART for ≥ 12 months, started during the chronic phase
- Plasma viral load ≤50 copies/mL for ≥ 6 months (one blip ≤200 copies/mL authorized)
- Blood CD4+ T cells count ≥ 350 cells/mm3
Key exclusion criteria (19 listed)
- HIV-2 infection
- Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) ; coeliac disease
- Platelets count <50 G/L or abnormal hemostasis tests
- Decompensated cirrhosis
- Past or current lymphoma
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 |
|---|---|---|
| Peripheral blood and intestinal biopsies will be collectedBlood draw and intestinal biopsies | Other | HIV-1 infected subjects, Uninfected-controls |
Primary outcome
Immune status: Measure of the frequencies of Th1 in peripheral blood and gut mucosa.
Time frame: Baseline
The frequencies of Th1 will be measured by flow cytometry.
Immune status: Measure of the frequencies of Th17 in peripheral blood and gut mucosa.
Time frame: Baseline
The frequencies of Th17 will be measured by flow cytometry.
Immune status: Measure of the frequencies of Th22 in peripheral blood and gut mucosa.
Time frame: Baseline
The frequencies of Th22 will be measured by flow cytometry.
9 secondary outcomes
Immune status: Quantification of cytokines in blood and gut mucosa.
Time frame: Baseline
Immune status: Quantification of cytokines in blood and gut mucosa.
Time frame: Baseline
Immune status: Quantification of chemiokines in blood and gut mucosa.
Time frame: Baseline
Immune status: Quantification of chemiokines in blood and gut mucosa.
Time frame: Baseline
Microbial translocation : Quantification of soluble CD14 in plasma.
Time frame: Baseline
Microbial translocation : Quantification of soluble soluble CD163 in plasma.
Time frame: Baseline
Microbial translocation : Quantification of Lipopolysaccharide Binding Protein (LBP).
Time frame: Baseline
Microbial translocation : Quantification of Intestinal-type Fatty Acid-Binding Protein (I-FABP) in plasma.
Time frame: Baseline
Microbial translocation : Quantification of 16S RNA.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Results publication: PubMed 32346082Nayrac M, Requena M, Loiseau C, Cazabat M, Suc B, Carrere N, Barange K, Alric L, Martin-Blondel G, Izopet J, Delobel P. Th22 cells are efficiently recruited in the gut by CCL28 as an alternative to CCL20 but do not compensate for the loss of Th17 cells in treated HIV-1-infected individuals. Mucosal Immunol. 2021 Jan;14(1):219-228. doi: 10.1038/s41385-020-0286-6. Epub 2020 Apr 28.
- Derived from this study: PubMed 40920867Collercandy N, Vellas C, Nayrac M, Requena M, Richarme T, Iscache AL, Latour J, Barange K, Alric L, Martin-Blondel G, Serino M, Izopet J, Delobel P. Cytotoxic CX3CR1+ Vdelta1 T cells clonally expand in an interplay of CMV, microbiota, and HIV-1 persistence in people on antiretroviral therapy. PLoS Pathog. 2025 Sep 8;21(9):e1013489. doi: 10.1371/journal.ppat.1013489. eCollection 2025 Sep.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral blood and intestinal biopsies will be collected in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 2 sites 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 14 inclusion and 19 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: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune status: Measure of the frequencies of Th1 in peripheral blood and gut mucosa. (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906137, which also lists 2 linked publications.
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 23 Apr 2026.