Investigating Autophagy in HIV-Infected Patients on Antiretroviral Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Orleans
  Orléans, France Recruiting

Study contacts

• Principal investigator: Laurent HOCQUELOUX, Dr — CHR d'orléans
• Study coordinator: Aurélie DESPUJOLS
• Email: aurelie.despujols@chr-orleans.fr
• Phone: 0238744071

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.