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)

Abstract

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 Two from the CBD-only arm were withdrawn for safety concerns: phlebotomy aggravating pre-existing anemia and severe hepatitis on 800 mg CBD with newly discovered pancreatic adenocarcinoma,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.

Anti-inflammatory effects of CBD in human microglial cell line infected with HIV-1

“…This study found that patients did not show safety concerns, and it was well-tolerated. However, there was no report about inflammatory levels, CD4 cell count, viral load, co-morbidities, etc 66 . Incorporating CBD or THC as therapeutic agents for HIV patients still requires more investigation to collect evidence on the HIV disease progression, viral latency, interaction with ART regimens, neurocognition, safety, and other co-morbidities.…”

Cannabinoids in Medicine: A Multifaceted Exploration of Types, Therapeutic Applications, and Emerging Opportunities in Neurodegenerative Diseases and Cancer Therapy

“…An additional layer of complexity is introduced by the dual nature of THC as both a partial agonist and antagonist for CB1R. Furthermore, THC can interact with other endocannabinoid receptors to exert anti-inflammatory effects [ 230 , 232 ].…”

Special Issue: Therapeutic Potential for Cannabis and Cannabinoids

“…The study also found that despite the use of medical cannabis, the majority of patients taking antidepressants and anxiolytic medications did not change their medications or the dose of these medications. Bouassa et al, found that THC and CBD were well-tolerated by patients with HIV on anti-retroviral therapy [ 9 ]. Their study did find that patients on high doses of CBD (800 mg/day) should be monitored for liver pathology.…”