Status:
COMPLETED
Effects of Cannabidiol (CBD) on the Activation of Autophagy and Inflammation Genes, Functional Consequences in Virologically Controlled HIV-infected Patients
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Conditions:
HIV Seropositivity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 cellu...
Detailed Description
The Centre of Molecular Biology of the CNRS in Orléans has developed for many years an expertise concerning apoptosis via the discovery of the GALIG gene. This pro-apoptotic gene produces two proteins...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05306249
Start Date
May 16 2022
End Date
February 8 2023
Last Update
April 3 2023
Active Locations (1)
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1
Centre Hospitalier Régional d'Orléans, France
Orléans, France, 45000