Effects of Cannabidiol (CBD) on the Activation of Autophagy and Inflammation Genes, Functional Consequences in Virologically Controlled HIV-infected Patients

CHRO-2021-01

Autophagy and apoptosis are natural cellular mechanisms which consist for the first in a recycling and elimination process of potentially toxic cellular waste, and for the second in a process of cellular suicide when it becomes abnormal and "not" repairable, notably by autophagy. A deficit in autophagic function at the cellular level can lead to chronic inflammation and accelerated cellular senescence. Apoptosis is a beneficial phenomenon because it eliminates abnormal cells that could endanger the organism if it survives (e.g. karyotypic atypia). Uncontrolled, it can be deleterious if apoptosis is hypo or hyperactive.

2022-05-16

2023-02-08

2023-02-08

Completed

Early phase I

80

Inclusion Criteria: * 1. Patient aged 18 or over at the time of signing the informed consent. * Adults living with HIV1 not co-infected with HIV2 * Documented evidence of HIV plasma RNA assays \<50 copies per ml during the 3 years preceding the inclusion, including tolerance of a few occasional "blips", * HIV 1 plasma RNA assay \<50 copies / ml at inclusion * Patient whose current antiretroviral therapy has not been interrupted during the three months prior to inclusion * Patient not taking recreational drugs including cannabis in the past six months * Affiliated with social security * Men or women. Women must not be pregnant or breastfeeding. If they are of childbearing potential, they should receive active contraception. * Be able to give informed written consent. Exclusion Criteria: * Women who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study * Any sign of active stage III disease as classified by the Centers for Diseases Control and Prevention * Patients whose antiretroviral therapy contains a strong cytochrome P3A4 inhibitor (ritonavir or cobicistat) or efavirenz * Patients receiving long-term NSAIDs or corticosteroids * Patients taking cannabis recreationally * Patients with a personal history of psychotic disorders * Patients with a history of severe cerebrovascular disease (ischemic or hemorrhagic stroke) * Renal failure defined by creatinine clearance \<60 mL / min calculated according to MDRD * Patient with severe hepatic impairment (class C) according to the Child Pugh score * Unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormality. * Disease or history of severe cardiovascular or cerebrovascular disorders (MI, stroke) * Anticipated need for hepatitis C virus treatment during the randomization phase of the study. * History or presence of allergy or intolerance to cannabidiol or to the terpenes contained in the study product. * Active malignant tumor * Patient who, in the opinion of the investigator, presents a significant risk of suicide * Any pre-existing physical or mental condition which may interfere with the patient's ability to comply with administration schedules and / or protocol evaluations, or which may compromise patient safety. * Any condition that is likely to interfere with the absorption, distribution, metabolism, or elimination of study drugs that may prevent the patient from taking oral therapy. * Non-observant patient * Persons covered by Article L.1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (including minors and protected adults). * Person under tutorship or curatorship * Person under safeguard of justice * Person not affiliated with a social security scheme * Patient participating in another clinical trial, evaluating a treatment * Patient with chronic inflammatory disease capable of altering the baseline level of cytokines

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2023-04-03