Investigating Autophagy in HIV-Infected Patients on Antiretroviral Therapy

Study of Autophagy and the Effects of GALIG Gene Products in HIV-1 Infected Patients Who Are Under Antiretroviral Therapy Since Primary-infection, Chronic Phase, or Never Treated.

This study is testing how well certain immune cells work in people with HIV who are on treatment, compared to healthy individuals, to see if problems with a process called autophagy are linked to ongoing inflammation.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Régional d'Orléans (Academic / other)
• Locations: 1 site (Orléans)
• Trial ID: NCT04160455 on ClinicalTrials.gov

What this trial studies

This study aims to explore the role of autophagy in HIV-infected patients who are undergoing antiretroviral therapy. It focuses on assessing whether specific immune cell populations, such as CD4+ and CD8+ T lymphocytes and monocytes, show defects in autophagy function. The study will compare these patients, who are virologically controlled, to a control group of healthy blood donors. By understanding the dysfunctions of autophagy in these patients, the research seeks to shed light on chronic inflammation and cellular senescence associated with HIV infection.

Who should consider this trial

Good fit: Ideal candidates include HIV-1 infected individuals aged 18 and older who are on suppressive antiretroviral therapy or have never been treated.

Not a fit: Patients co-infected with HIV-2 or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for HIV-infected patients by addressing autophagy-related dysfunctions.

How similar studies have performed: While there is limited research on autophagy in HIV-infected patients, previous studies have indicated significant dysfunctions, suggesting this area is ripe for exploration.

Eligibility criteria

Inclusion Criteria:

General criteria:

* Age \>=18 years
* Man or woman
* Infected with HIV-1 (and not co-infected with HIV-2)
* Followed at Orleans' Regional Hospital
* Patient belonging to one of the predefined cohorts/groups (see below)
* Patient having provided a written consent

Specific profiles of HIV-infected patients for the ATGALIG-HIV study:

Cohort A: patients on suppressive antiretroviral therapy (HIV RNA \<50 copies / ml for at least 4 years) initiated during the chronic phase, divided into 2 groups according to the following criteria:

* group A1: CD4 count less than 500 cells / ml at the time of inclusion in the study
* group A2: CD4 count above 500 cells / ml at the time of inclusion in the study Cohort B: patients on suppressive antiretroviral therapy (HIV RNA \<50 copies / ml for at least 4 years) initiated since the primary-infection (within 4 months after acute infection)

Cohort C: patients with detectable HIV RNA, naïve of antiretroviral, but who have an indication to start antiretroviral therapy, divided into the following 3 groups:

* group C1: HIV diagnosis made during primary infection (within 4 months of infection)
* group C2: HIV diagnosis made during the chronic phase (more than 1 year after contamination), with CD4 count above 200 cells/ml at the time of inclusion in the study
* group C3: HIV diagnosis made during the chronic phase (more than 1 year after contamination), with CD4 count less than 200 cells/ml at the time of inclusion in the study Cohort D: patients who have undetectable plasma HIV RNA (HIV RNA \<50 copies / ml ) without antiretroviral therapy, either spontaneously (HIV controllers or elite controllers) or after treatment interruption (post-treatment controllers)

Exclusion Criteria:

* Patient unable, according to the investigator, to meet the requirements of the protocol
* Pregnant or lactating woman
* Patient with a history of inflammatory bowel disease, malignancy, intestinal ischemia, malabsorption or other gastrointestinal dysfunction that, in the judgment of the investigator, could interfere with the interpretation of the results.
* Presence of coagulation abnormality or unexplained bleeding history
* Treatment with oral or injectable anticoagulant (curative or preventive)
* Patient covered by Article L.1121-5 to L.1121-8 and L.1122-1-2 of the French Public Health Code (including minors and protected adults)
* Patient under guardianship or curatorship
* Patient who uncovered by French health insurance Patient participating in another clinical trial, evaluating a treatment

Where this trial is running

Orléans

• CHU Orleans — Orléans, France (Recruiting)

Study contacts

• Principal investigator: Laurent HOCQUELOUX, Dr — CHR d'orléans
• Study coordinator: Aurélie DESPUJOLS

Conditions Autophagy; Galectins; HIV Infections; Highly Active Antiretroviral Therapy; Antiretroviral therapy; basal autophagy; GALIG gene; HIV