Background
People with long-term controlled HIV (PWH) suffer from inflammaging, characterized by chronic inflammation and immunosenescence. As cannabis smokers display immune beneficial effects such as lower levels of inflammation and as the popularity of cannabidiol (CBD) products increases, we evaluated the safety of a full-spectrum cannabidiol drug for the first time on PWH. The new results presented herein are in direct link with our previously published analyses showing limited impact on health-related quality of life.
Methods
This double-blind, randomized, placebo-controlled trial was registered on ClinicalTrials.gov as NCT05306249. Eighty ART-treated PWH with undetectable viremia (median time on efficient ART 14 years, median age 54-year-old), were included, encompassing 30% women. Half took 1mg/kg twice a day of a full-spectrum, pharmaceutical grade, CBD oil for 12 weeks and the other half took a placebo medium-chain triglyceride oil. An additional follow up was done at week 16. We evaluated the treatment impact on hemodynamic with electrocardiograms, HIV follow up and both liver and kidney functions were assessed with whole blood dosages.
Results
No significant difference in adverse events, whether mild or serious, were detected between the CBD arm (58) and the placebo one (57). We highlighted that there was also no change in plasmatic viral load, DNA proviral levels and CD4/CD8 ratio. Systolic and diastolic blood pressure (SBP and DBP) were not impacted by the treatment as well. Interestingly, for men but not for women, median heart rate was lowered from 71.1 to 64 bpm after 12 weeks of CBD treatment, and persisted until at least 4 more weeks. Moreover, the safety of the full-spectrum drug on kidney and liver was evidenced with no significant effect on creatininemia, ASAT, ALAT and conjugated bilirubin levels. Yet, a mixed model, considering time and group, showed that total bilirubin rate was lowered after 12 weeks of CBD intake.
Conclusions
To conclude, pharmaceutical grade full-spectrum CBD oil, at 1mg/kg twice a day, is not associated with any impaired function or adverse events but other studies found that, at high doses, hepatic deleterious effects can occur. This suggests that, at a low dose, it could be safe for PWH with potential beneficial effects on total bilirubin and men heart rate.
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