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

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Criteria

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