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  • Oral cannabinoids in people living with HIV on effective antiretroviral therapy: CTN PT028—study protocol for a pilot randomised trial to assess safety, tolerability and effect on immune activation

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HIV/AIDS
Protocol
Oral cannabinoids in people living with HIV on effective antiretroviral therapy: CTN PT028—study protocol for a pilot randomised trial to assess safety, tolerability and effect on immune activation
  1. Cecilia T Costiniuk1,2,
  2. Zahra Saneei1,
  3. Jean-Pierre Routy1,2,
  4. Shari Margolese3,
  5. Enrico Mandarino3,4,
  6. Joel Singer3,5,
  7. Bertrand Lebouché1,2,6,
  8. Joseph Cox1,2,6,
  9. Jason Szabo1,2,6,
  10. Marie-Josée Brouillette1,2,7,
  11. Marina B Klein1,2,
  12. Nicolas Chomont8,
  13. Mohammad-Ali Jenabian9
  1. 1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Canada
  2. 2 Research Institute of McGill University Health Centre, Montreal, Canada
  3. 3 Canadian Institutes of Health Research Canadian HIV Trials Network, Vancouver, British Columbia, Canada
  4. 4 WILLL Cannabis Group, Toronto, Canada
  5. 5 School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada
  6. 6 Department of Family Medicine, McGill University Health Centre, Montreal, Canada
  7. 7 Department of Psychiatry, McGill University Health Centre, Montreal, Canada
  8. 8 Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Université de Montréal, Montreal, Canada
  9. 9 Department of Biological Sciences and BioMed Research Centre, University of Quebec at Montreal (UQAM), Montreal, Quebec, Canada
  1. Correspondence to Dr Cecilia T Costiniuk; cecilia.costiniuk{at}mcgill.ca

Abstract

Introduction Despite antiretroviral therapy (ART), people living with HIV have higher rates of non-infectious chronic diseases. These conditions are driven by relatively high levels of inflammation persisting on ART compared with uninfected individuals. Chronic inflammation also contributes to HIV persistence during ART. Cannabis when taken orally may represent a way to reduce inflammation and strengthen immune responses. Before planning large interventional studies, it is important to ensure that cannabis taken orally is safe and well tolerated in people living with HIV. We propose to conduct a pilot randomised trial to examine the safety and tolerability of cannabis oils containing tetrahydrocannabinol (THC) and cannabidiol (CBD) consumed orally in people living with HIV. We will also measure inflammatory markers, markers of HIV persistence in peripheral blood cells and changes in the gastrointestinal microbiome.

Methods and analysis Twenty-six people living with HIV having undetectable viral load for at least 3 years will be randomised to receive TN-TC11LM (THC:CBD in 1:1 ratio) or TN-TC19LM (THC:CBD in 1:9 ratio) capsules daily for 12 weeks. Safety and tolerability of these capsules will be assessed through haematological, hepatic and renal blood tests, face-to-face interviews and questionnaires. Proportions of participants without any signs of significant toxicity (grades 0–2 scores on the WHO toxicity scale) and who complete the study, as well as scores on quality of life and mood will be examined using descriptive statistics. The effects on inflammatory markers, markers of peripheral blood reservoir size and effect on the composition of the gastrointestinal microbiome will be assessed before and after study completion.

Ethics and dissemination This study has been approved by the Research Institute of the McGill University Health Centre. A Data Safety Monitor will review safety information at regular intervals. The final manuscript will be submitted to an open-access journal within 6 months of study completion.

Trial registration number NCT03550352.

  • cannabinoids
  • cannabis
  • safety and tolerability
  • inflammation
  • immune activation
  • HIV reservoir

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2018-024793

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    Footnotes

    • Patient consent for publication Not required.

    • Contributors CTC conceived and designed the study, drafted the grant and the protocol manuscript, will organise and supervise trial implementation and will be responsible for trial management. She will also be responsible for trial managements, staff training and supervision. M-AJ contributed to study design and participated in grant writing. ZS, BL, J-PR, JC, JaS, M-JB and MBK will participate in study implementation. M-JB provided input on questionnaires, while CTC and M-AJ provided immunological expertise and NC provided expertise related to the HIV reservoir. SM and EM contributed to study design. CTC, M-AJ and NC designed the experiments. JoS contributed to the statistical analysis plan. CTC, M-AJ and NC designed the experiments. All authors participated in refinement of the study methods, critically reviewed the manuscript drafts and approved the final manuscript. The CTN provides regulatory support. CTC and BL are Fonds de recherche du Québec-Santé (FRQ-S) chercheur-boursier-clinicien junior 1. BL holds a Strategy for Patient-Oriented Research (SPOR) Mentorship Chair in Innovative Clinical Trials. J-PR holds the Louis Lowenstein Chair in Hematology and Oncology at McGill University. M-AJ is holder of a Tier 2 Canada Research Chair in immunovirology.

    • Funding This work is supported by the CIHR Canadian HIV Trials Network.

    • Competing interests Tilray Inc is supplying the study medications free of charge. All elements of the study are being undertaken independently of Tilray Inc. The authors declare there are no conflicts of interests.

    • Ethics approval The study protocol and informed consent have been approved by the Research Ethics Board of the McGill University Health Centre (MUHC-2018–4336).

    • Provenance and peer review Not commissioned; externally peer reviewed.