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Leaky gut in treated HIV: scientists probe why immune repair fails

NCT ID NCT02906137

Knowledge-focused Sponsor: ANRS, Emerging Infectious Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study investigates why the gut immune barrier remains damaged in people with HIV even after successful antiretroviral therapy. Researchers collected blood and intestinal biopsies from 80 participants to measure immune cells and inflammation. The goal is to understand why the gut doesn't fully recover, which could help reduce long-term health problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could point toward new ways to help the gut immune system recover in people living with HIV, potentially reducing long-term inflammation.
What could go wrong
This is an observational study, not a treatment trial. It aims to understand the problem, not test a solution. Results may not lead directly to new therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Feb 2017

Finished

Feb 2020

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria are: 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 * 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 Exclusion Criteria are: 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 * 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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

Contacts and locations

Locations

  • Hôpital Purpan - Service de Médecine Interne

    Toulouse, 31059, France

  • Hôpital Purpan - Service des maladies Infectieuses

    Toulouse, 31059, France

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