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Study breakdown

Oral Cannabinoids Appeared Safe in People Living with HIV on Antiretroviral Therapy

Pilot StudyPreliminary evidence
The takeaway

In a small pilot trial, oral cannabinoids (THC:CBD combination or CBD alone) were generally safe and well-tolerated in people with HIV on long-term antiretroviral therapy, with stable CD4 counts and viral suppression.

People living with HIV, infectious disease physicians, HIV researchers

CD4 count and viral suppression remained stable

What the researchers found

Eight of ten HIV-positive participants completed 12 weeks of treatment. Seven experienced no significant toxicity. Two withdrawals from the CBD-only arm were for pre-existing conditions (anemia aggravated by phlebotomy and hepatitis with newly discovered pancreatic cancer). CD4 count, CD4/CD8 ratio, and HIV suppression remained stable throughout.

Why it matters

People living with HIV experience chronic immune activation even on effective antiretroviral therapy. Cannabinoids' anti-inflammatory properties could theoretically help, but safety data in this population has been lacking.

The numbers in context

10 participants; 8 completed; THC:CBD max 15mg/15mg daily; CBD-only max 800mg daily; 12 weeks; CD4 and viral load stable; 7/10 no significant toxicity

How the study worked

Open-label interventional pilot study at McGill University Health Centre. Participants randomized to oral THC:CBD (2.5mg/2.5mg, titrated to 15mg/15mg daily) or CBD-only (200mg, titrated to 800mg daily) for 12 weeks. Primary outcome: percentage without significant WHO toxicity.

What this study cannot tell us

Very small sample (10 participants). Open-label without placebo control. Two withdrawals from the CBD arm for issues that may not be related to the study drug. Cannot assess efficacy.

How to read the evidence

Very small open-label pilot (n=10) focused on safety and tolerability rather than efficacy.

When this study was published

Published in 2022

The bigger picture

Many people with HIV already use cannabis. This pilot provides preliminary safety data to inform larger trials investigating whether cannabinoids can reduce chronic immune activation in HIV.

Questions still open

  • Would cannabinoids reduce chronic immune activation in HIV in a larger trial? Should liver function be routinely monitored in HIV patients using high-dose CBD?

Common questions

Is cannabis safe for people with HIV?
This small pilot trial found oral cannabinoids (THC:CBD or CBD alone) were generally safe in HIV patients on antiretroviral therapy, with stable CD4 counts and viral suppression. Larger studies are needed to confirm safety.
Did cannabinoids interfere with HIV medication?
No. CD4 counts, CD4/CD8 ratios, and HIV viral suppression remained stable throughout the 12-week study. However, the authors recommended monitoring liver enzymes, especially with high CBD doses.

Read the original research

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).

Biomedicines, 10(12)

Citation

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. (2022). 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).. Biomedicines, 10(12). https://doi.org/10.3390/biomedicines10123168

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