Cannabinoids in PLWHIV on Effective ART

• Status: Not yet recruiting
• Trial end date: 2022-08-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to assess feasibility and to examine whether oral cannabinoids (capsules containing either Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) combined or CBD alone) are safe and well-tolerated in people living with HIV. Other aims are to determine whether oral cannabinoids may reduce HIV-associated inflammation. An exploratory objective is to determine whether oral cannabinoids may influence HIV persistence as well as the gastrointestinal microbiome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Centre de Recherche du Centre Hospitalier de l'Université de Montréal; CIHR Canadian HIV Trials Network; Tilray; Université du Québec a Montréal

Criteria

Inclusion Criteria:

• Participants must meet all of the following criteria within 4 weeks prior to the week 0 (Baseline 1) visit to be considered eligible for entry into the study:

1. Documented HIV infection by Western Blot, EIA assays or viral load assays

2. Male or female, Aged 18 or older

3. Viral load <40 copies/ml for at least 3 years

4. On ART for at least 3 years

5. No cannabinoid use for at least 1 month prior to enrolment with negative baseline cannabinoid screen

6. Able to communicate adequately in either French or English

7. Able and willing to provide written informed consent prior to enrolment including access to relevant medical records

Exclusion Criteria:

1. Using cannabinoid-containing products outside of the study or within 4 weeks of study commencement

2. Pregnant, breastfeeding or planning to become pregnant during the course of the study. Female participants must undergo a pregnancy test and obtain a negative result in order to qualify for study participation.

3. Enrolled in a separate study involving administration of medication, vitamin, supplement or herbal product.

4. Active intravenous drug users

5. Active substance dependence

6. Prior history of hypersensitivity to cannabis or cannabis-containing products

7. Known or suspected allergy to sunflower lecithin oil

8. Active opportunistic infection or malignant condition

9. Unintentional weight loss of 10 % or more of body weight in the last 6 months

10. Unstable angina or acute cardiac event in the past year

11. Active psychiatric disorder or history of psychiatric depression (other than mild depression or anxiety); On antipsychotic medication

12. Known or suspected family history of schizophrenia or severe personality disorder

13. Serious cardiovascular disease such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or severe heart failure

14. Anemia (Hemoglobin <100 g/L)

15. Active liver disease or unexplained persistent elevations of serum transaminases

16. Co-infection with Hepatitis B or C (positive HBsAg or positive anti-HBc antibodies with a detectable HBV DNA viral load or positive anti HCV antibodies with a detectable HCV RNA viral load)

17. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) or alkaline phosphatase >2.5 x upper limit of normal (ULN)

18. Active AIDS event in the last month as determined by the treating physician

19. Renal dysfunction

20. Unstable psychological or psychiatric condition as determined by the treating physician

21. Holding employment which requires operation of heavy machinery or which requires undergoing drug screening (i.e., pilot or police officer)

22. Concurrent use within the past 8 week of anabolic hormones, prednisone, IL-2 or other agents known to alter immune function.