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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) †

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 Universit...

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Autores principales: Mboumba Bouassa, Ralph-Sydney, Needham, Judy, Nohynek, Dana, Singer, Joel, Lee, Terry, Bobeuf, Florian, Samarani, Suzanne, Del Balso, Lina, Paisible, Natalie, Vertzagias, Claude, Sebastiani, Giada, Margolese, Shari, Mandarino, Enrico, Klein, Marina, Lebouché, Bertrand, Cox, Joseph, Brouillette, Marie-Josée, Routy, Jean-Pierre, Szabo, Jason, Thomas, Réjean, Huchet, Emmanuel, Vigano, Antonio, Jenabian, Mohammad-Ali, Costiniuk, Cecilia T
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9775551/
https://www.ncbi.nlm.nih.gov/pubmed/36551926
http://dx.doi.org/10.3390/biomedicines10123168
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author Mboumba Bouassa, Ralph-Sydney
Needham, Judy
Nohynek, Dana
Singer, Joel
Lee, Terry
Bobeuf, Florian
Samarani, Suzanne
Del Balso, Lina
Paisible, Natalie
Vertzagias, Claude
Sebastiani, Giada
Margolese, Shari
Mandarino, Enrico
Klein, Marina
Lebouché, Bertrand
Cox, Joseph
Brouillette, Marie-Josée
Routy, Jean-Pierre
Szabo, Jason
Thomas, Réjean
Huchet, Emmanuel
Vigano, Antonio
Jenabian, Mohammad-Ali
Costiniuk, Cecilia T
author_facet Mboumba Bouassa, Ralph-Sydney
Needham, Judy
Nohynek, Dana
Singer, Joel
Lee, Terry
Bobeuf, Florian
Samarani, Suzanne
Del Balso, Lina
Paisible, Natalie
Vertzagias, Claude
Sebastiani, Giada
Margolese, Shari
Mandarino, Enrico
Klein, Marina
Lebouché, Bertrand
Cox, Joseph
Brouillette, Marie-Josée
Routy, Jean-Pierre
Szabo, Jason
Thomas, Réjean
Huchet, Emmanuel
Vigano, Antonio
Jenabian, Mohammad-Ali
Costiniuk, Cecilia T
author_sort Mboumba Bouassa, Ralph-Sydney
collection PubMed
description 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.
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spelling pubmed-97755512022-12-23 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) † Mboumba Bouassa, Ralph-Sydney Needham, Judy Nohynek, Dana Singer, Joel Lee, Terry Bobeuf, Florian Samarani, Suzanne Del Balso, Lina Paisible, Natalie Vertzagias, Claude Sebastiani, Giada Margolese, Shari Mandarino, Enrico Klein, Marina Lebouché, Bertrand Cox, Joseph Brouillette, Marie-Josée Routy, Jean-Pierre Szabo, Jason Thomas, Réjean Huchet, Emmanuel Vigano, Antonio Jenabian, Mohammad-Ali Costiniuk, Cecilia T Biomedicines Article 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. MDPI 2022-12-07 /pmc/articles/PMC9775551/ /pubmed/36551926 http://dx.doi.org/10.3390/biomedicines10123168 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Mboumba Bouassa, Ralph-Sydney
Needham, Judy
Nohynek, Dana
Singer, Joel
Lee, Terry
Bobeuf, Florian
Samarani, Suzanne
Del Balso, Lina
Paisible, Natalie
Vertzagias, Claude
Sebastiani, Giada
Margolese, Shari
Mandarino, Enrico
Klein, Marina
Lebouché, Bertrand
Cox, Joseph
Brouillette, Marie-Josée
Routy, Jean-Pierre
Szabo, Jason
Thomas, Réjean
Huchet, Emmanuel
Vigano, Antonio
Jenabian, Mohammad-Ali
Costiniuk, Cecilia T
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) †
title 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) †
title_full 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) †
title_fullStr 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) †
title_full_unstemmed 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) †
title_short 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) †
title_sort 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) †
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9775551/
https://www.ncbi.nlm.nih.gov/pubmed/36551926
http://dx.doi.org/10.3390/biomedicines10123168
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