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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.

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.

Recruiting
18 years and older
All
Phase N/A

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Overview

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).

Eligibility

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

Study details
    Autophagy
    Galectins
    HIV Infections
    Highly Active Antiretroviral Therapy

NCT04160455

Centre Hospitalier Régional d'Orléans

26 January 2024

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