Dr. Cecilia Costiniuk
Co-Leader, Vaccines and Immunotherapies Core
McGill University Health Centre
View BioCannabis
Clinical Care and Management (CCM)
About The Study
Living with HIV is associated with higher rates of some chronic diseases and a relatively high level of inflammation within the body. Marijuana has anti-inflammatory properties that may be useful in counteracting this state of chronic inflammation. There is also evidence that it may have positive effects on immune function while reducing the harmful immune activation that contributes to inflammation. CNTPT 028, taking place at McGill University, is a small pilot study that will primarily look at the feasibility, safety, and tolerability of cannabinoid oil in people living with HIV. Secondarily, it will test the effects of cannabinoid oils on immune function and inflammation.
About The Disease
In the past, cannabis has been used to manage HIV-associated neuropathy and chronic pain and to stimulate appetite to combat AIDS wasting syndrome. More recently, laboratory and animal studies suggest that cannabinoids have immunosuppressive effects—reducing T-cell activation, HIV production, and inflammatory markers—ultimately pointing towards the ability of these naturally occurring drugs to reduce immune activation.
Despite the potentially positive effects of marijuana for people living with HIV, only one study has tested its effect on immune function. No studies have tested its effect on inflammation or on the viral reservoir size (the amount of HIV that remains hidden in immune cells).
Study Approach
Twenty-six participants will receive capsules for oral ingestion containing cannabinoid oils in a set ratio of tetrahydrocannabinol (THC) and cannabidiol (CBD) or CBD-only for 12 weeks. Half of the participants will be randomized to the THC:CBD combination arm (2.5 mg THC: 2.5 mg CBD per capsule) while the other half of participants will be randomized to the CBD-only arm (200 mg CBD per capsule). Participants in the THC:CBD combination arm will take 1 capsule twice daily for 2 weeks and increase the number of capsules, as tolerated, to a maximum of 6 capsules taken throughout the day. The other participants will start by taking 1 CBD-only capsule once daily for 2 weeks and increase the number of capsules, as tolerated, to a maximum of 4 capsules taken throughout the day. Toxicity and study completion will be the main outcomes however changes in quality of life, mood, immune function, and inflammation will also be measured using questionnaires and blood draws.
Eligibility Requirements
Required
- Age 18 years or older
- Laboratory documentation of HIV infection
- On antiretroviral therapy (ART) for at least 3 years
- Individuals will have suppressed viral load ≥3 years
- No cannabinoid use for ≥1 month prior to enrolment as verified by negative baseline urine cannabinoid screen
Not Allowed
- Pregnant women or women trying to become pregnant
- Active intravenous drug users
- Active substance dependence
- Prior history of hypersensitivity to marijuana or cannabis-containing products
- Active opportunistic infection or malignant condition
- Unintentional weight loss of 10% or more of body weight in the last 6 months
- Unstable angina (chest pain) or acute cardiac event in the past year
- Active psychiatric disorder or history of psychiatric depression (other than mild depression or anxiety)
on antipsychotic medication - Active liver disease
- Hepatitis B or C infection
- Holding a job which requires operation of heavy machinery or to undergo drug screening (ie, pilot or police officer)
- Concurrent use within the past 8 weeks of anabolic hormones, prednisone, IL-2 or other agents known to alter immune system function
For full eligibility criteria, visit clinicaltrials.gov.
Additional Information
If you would like more information on this clinical study, please contact Claude Vertzagias (Research Coordinator):
Phone: 514.934-1934 ext 37677
Email: claude.vertzagias@muhc.mcgill.ca
Principal Investigator
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Participating Site
McGill University Health Centre Chronic Viral Illness Service
Royal Victoria Hospital, Glen Site
1001 Décarie Blvd.
Montréal, QC
Naiana Muntini
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