Informations générales (source: ClinicalTrials.gov)
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. (ATGALIG-HIV)
Observational
Centre Hospitalier Régional d'Orléans (Voir sur ClinicalTrials)
novembre 2019
novembre 2039
05 avril 2025
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).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHR d'Orleans - 45067 - Orléans - France | Laurent HOCQUELOUX, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
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)
- 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