HIV Infections Clinical Trial
Official title:
Cannabinoids in People Living With HIV on Effective Antiretroviral Therapy: A Pilot Study to Assess Safety, Tolerability and Effect on Immune Activation
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Chronic Viral Illnesses Service, McGill University Health Centre-Glen Site | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre | Centre de Recherche du Centre Hospitalier de l'Université de Montréal, CIHR Canadian HIV Trials Network, Tilray, Université du Québec a Montréal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | WHO toxicity scale | Proportions of participants in both groups without any signs of significant toxicity as determined by the WHO toxicity scale (i.e., number of participants with Grades 0-2 scores on the WHO toxicity scale) Proportion of participants in both groups without any signs of significant haematological, biochemical, hepatic, renal, cardiovascular, respiratory, gastrointestinal, neurological, musculoskeletal, dermatological or systemic toxicity (Grades 0-2) as determined by the World Health Organization Toxicity Grading Scale for Determining the Severity of Adverse events (Grades 0=no toxicity; Grade 1=mild, transient or mild discomfort vs. maximum score Grade 4=life-threatening, extreme limitation in activity, significant assistance required) Toxicity scores (Grade 0, 1, 2, 3, or 4) will be calculated and reported for each domain (hematology, biochemistry, hepatic enzymes, urinalysis, cardiovascular, respiratory, gastrointestinal, neurological, musculoskeletal, dermatological, systemic) |
week 0-12 | |
Secondary | Change in immune cell profile | Change in CD4 count and their subsets including naïve, central memory and effector memory, Treg and Th17 cells from week 0 to week 12 Change in immune cell profile (frequencies of CD4 T cell counts and their subsets such as naïve, central memory and effector memory T cells; T regulatory cells; Th17 cells) from week 0 to week 12 | week 0-12 | |
Secondary | Change in plasma inflammatory markers | Change in plasma inflammatory markers from week 0 to week 12 Change in concentration of plasma inflammatory markers (interferon-a, interleukin-1ß, interleukin-6, interleukin-10, interleukin-17, Transforming Growth Factor-ß, interferon-gamma-induced protein-10, d-dimer, C-reactive protein, lipopolysaccharide and soluble CD14) from week 0 to week 12 | week 0-12 | |
Secondary | Change in proportion activated CD4 and CD8 T cell lymphocytes | Change in CD8+CD38+HLADR+ and CD4+CD38+HLADR+ percentages from week 0 to 12 weeks Change in proportion activated CD4 and CD8 T cell lymphocytes (CD38+HLADR+) from week 0 to 12 weeks |
week 0-12 |
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