Safety and Tolerability of Oral Cannabinoids in People Living with HIV on Long-Term ART: A Randomized, Open-Label, Interventional Pilot Clinical Trial (CTNPT 028).

Autor:	Mboumba Bouassa RS; Department of Biological Sciences and CERMO-FC Research Centre, Université du Québec à Montréal, Montreal, QC H2X 3Y7, Canada.; Infectious Diseases and Immunity in Global Health Program, Research Institute of McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Needham J; CIHR Canadian HIV Trials Network, Vancouver, BC V6Z 1Y6, Canada.; Centre for Health Evaluation and Outcome Sciences, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada., Nohynek D; CIHR Canadian HIV Trials Network, Vancouver, BC V6Z 1Y6, Canada.; Centre for Health Evaluation and Outcome Sciences, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada., Singer J; CIHR Canadian HIV Trials Network, Vancouver, BC V6Z 1Y6, Canada.; Centre for Health Evaluation and Outcome Sciences, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.; School of Population and Public Health, University of British Columbia, Vancouver, BC V6T 1Z4, Canada., Lee T; CIHR Canadian HIV Trials Network, Vancouver, BC V6Z 1Y6, Canada.; Centre for Health Evaluation and Outcome Sciences, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada., Bobeuf F; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Samarani S; Infectious Diseases and Immunity in Global Health Program, Research Institute of McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Del Balso L; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Paisible N; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Vertzagias C; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Sebastiani G; Infectious Diseases and Immunity in Global Health Program, Research Institute of McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Margolese S; CIHR Canadian HIV Trials Network, Vancouver, BC V6Z 1Y6, Canada., Mandarino E; CIHR Canadian HIV Trials Network, Vancouver, BC V6Z 1Y6, Canada., Klein M; Infectious Diseases and Immunity in Global Health Program, Research Institute of McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Lebouché B; Infectious Diseases and Immunity in Global Health Program, Research Institute of McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Family Medicine, McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Canadian Institutes of Health Research Strategy for Patient-Oriented Research Mentorship Chair in Innovative Clinical Trials, Montreal, QC H4A 3J1, Canada., Cox J; Infectious Diseases and Immunity in Global Health Program, Research Institute of McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Brouillette MJ; Infectious Diseases and Immunity in Global Health Program, Research Institute of McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Psychiatry, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Routy JP; Infectious Diseases and Immunity in Global Health Program, Research Institute of McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Hematology, McGill University Health Centre, Montreal, QC H4A 3J1, Canada., Szabo J; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Family Medicine, McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Clinique Médical L'Actuel, Montreal, QC H2L 4P9, Canada., Thomas R; Clinique Médical L'Actuel, Montreal, QC H2L 4P9, Canada., Huchet E; Clinique Médical L'Agora, Montreal, QC H2L 4E9, Canada., Vigano A; Medical Cannabis Program in Oncology, Cedars Cancer Center, McGill University Health Centre, 1001 Boulevard Decarie, Montreal, QC H4A 3J1, Canada.; Centre for Cannabis Research, McGill University, Montreal, QC H3A 0G4, Canada., Jenabian MA; Department of Biological Sciences and CERMO-FC Research Centre, Université du Québec à Montréal, Montreal, QC H2X 3Y7, Canada.; Department of Microbiology, Infectiology and Immunology, Université de Montréal, Montreal, QC H3T 1J4, Canada., Costiniuk CT; Infectious Diseases and Immunity in Global Health Program, Research Institute of McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Department of Medicine, Division of Infectious Diseases and Chronic Viral Illnesses Service, McGill University Health Centre, Montreal, QC H4A 3J1, Canada.; Centre for Cannabis Research, McGill University, Montreal, QC H3A 0G4, Canada.; Department of Microbiology and Immunology, McGill University, Montreal, QC H3A 0G4, Canada.
Jazyk:	angličtina
Zdroj:	Biomedicines [Biomedicines] 2022 Dec 07; Vol. 10 (12). Date of Electronic Publication: 2022 Dec 07.
DOI:	10.3390/biomedicines10123168
Abstrakt:	Background: With anti-inflammatory properties, cannabinoids may be a potential strategy to reduce immune activation in people living with HIV (PLWH) but more information on their safety and tolerability is needed. Methods: We conducted an open-label interventional pilot study at the McGill University Health Centre in Montreal, Canada. PLWH were randomized to oral Δ9-tetrahydrocannabinol (THC): cannabidiol (CBD) combination (THC 2.5 mg/CBD 2.5 mg) or CBD-only capsules (CBD 200 mg). Individuals titrated doses as tolerated to a maximum daily dose THC 15 mg/CBD 15 mg or 800 mg CBD, respectively, for 12 weeks. The primary outcome was the percentage of participants without any significant toxicity based on the WHO toxicity scale (Grades 0-2 scores). Results: Out of ten individuals, eight completed the study. Two from the CBD-only arm were withdrawn for safety concerns: phlebotomy aggravating pre-existing anemia and severe hepatitis on 800 mg CBD with newly discovered pancreatic adenocarcinoma, respectively. Seven did not have any significant toxicity. Cannabinoids did not alter hematology/biochemistry profiles. CD4 count, CD4/CD8 ratio, and HIV suppression remained stable. Most adverse effects were mild-moderate. Conclusions: In PLWH, cannabinoids seem generally safe and well-tolerated, though larger studies are needed. Screening for occult liver pathology should be performed and hepatic enzymes monitored, especially with high CBD doses.
Databáze:	MEDLINE
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