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.
| NCT ID | NCT04160455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional d'Orléans |
| Condition | Autophagy |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2019-11-07 |
| Primary Completion | 2029-11-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2019-11-07 with a primary completion date of 2029-11-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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
Contact & Investigator
Laurent HOCQUELOUX, Dr
PRINCIPAL INVESTIGATOR
CHR d'orléans
Frequently Asked Questions
Who can join the NCT04160455 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autophagy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04160455 currently recruiting?
Yes, NCT04160455 is actively recruiting participants. Contact the research team at aurelie.despujols@chr-orleans.fr for enrollment information.
Where is the NCT04160455 trial being conducted?
This trial is being conducted at Orléans, France.
Who is sponsoring the NCT04160455 clinical trial?
NCT04160455 is sponsored by Centre Hospitalier Régional d'Orléans. The principal investigator is Laurent HOCQUELOUX, Dr at CHR d'orléans. The trial plans to enroll 180 participants.