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RECRUITING

NCT04160455

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.

Sponsor: Centre Hospitalier Régional d'Orléans

View on ClinicalTrials.gov

Summary

Little is known about autophagy during HIV infection. Recently, two different teams reported important dysfunctions of autophagy in HIV-infected patients despite sustained suppressive antiretroviral therapy. As altered autophagy is strongly linked to cellular senescence and chronic inflammation, two hallmarks of HIV-infected patients despite long-term suppressive antiretroviral therapy, it is important to improve our knowledge in the area. Our main objective is to determine whether all or part of mononuclear cell subpopulations (CD4+ and CD8+ T lymphocytes, and monocytes) exhibit a defect in autophagy function in a cohort of HIV-infected patients who are virologically-controlled (plasma HIV RNA \<50 copies / ml) either spontaneously (i.e. HIV controllers or post-treatment controllers) or after they started antiretroviral therapy at different time points (i.e. at the acute or chronic phases), as compared with a control group (i.e. uninfected healthy blood donors).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2019-11-07

Completion Date

2039-11-07

Last Updated

2025-12-30

Healthy Volunteers

Conditions

Autophagy Galectins HIV Infections Highly Active Antiretroviral Therapy

Interventions

BIOLOGICAL

expression of a panel

Quantify, by droplet digital PCR, the expression of a panel of 7 genes (+ GALIG) involved in autophagy2 on sub-populations (CD4+ and CD8+ lymphocytes and monocytes) after their sorting using magnetic bead cell then RNA extraction Evaluate, on a functional test (as previously described1), whether the observed expression dysregulation is associated with a deregulation of the autophagic function, whether constitutive or induced.

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

Locations (1)

CHU Orleans

Orléans, France