Cannabinoids in PLWHIV on Effective ART
Raktažodžiai
Santrauka
apibūdinimas
Adults with well-controlled HIV (viral load suppressed for at least 3 years on effective antiretrovirals) will be randomized to receive Tilray oral capsules containing THC and CBD in oil format in 2 different ratios of THC and CBD: CBD Low dose TN-TC11LM oral capsules (THC 2.5 mg / CBD 2.5 mg) vs. High CBD dose TN-TC19LM oral capsules (THC 5 mg / CBD 45 mg). Participants will titrate up the number of capsules consumed based on their own individual tolerability, to a specified maximum daily dose, for a total treatment duration of 12 weeks.
Participants will be assessed regularly via history and physical exam as well as through safety blood work monitoring (hematology and chemistry profiles, liver enzymes, renal function, HIV viral loads, CD4 and CD8 counts). Effect on mood and quality of life will be determined by WHO-QOL-HIV-BREF, EQ-5D and Profile of Mood States questionnaires. Blood work for immune activation and inflammatory profiles, as well as HIV reservoir, will also be drawn at regular intervals.
This pilot study will provide information on feasibility (ie, time to recruitment of participants, whether participants continue the study for the full 12 week duration and complete the follow-up visits and questionnaires, whether treatment is safe and well-tolerated). It will also provide some preliminary data on the ability of TN-TC11LM and TN-TC19LM oral capsules to reduce inflammation and possibly influence HIV persistence.
Datos
| Paskutinį kartą patikrinta: | 05/31/2018 |
| Pirmasis pateikimas: | 05/22/2018 |
| Numatytas registravimas pateiktas: | 06/05/2018 |
| Pirmas paskelbtas: | 06/07/2018 |
| Paskutinis atnaujinimas pateiktas: | 06/05/2018 |
| Paskutinis atnaujinimas paskelbtas: | 06/07/2018 |
| Faktinė studijų pradžios data: | 07/31/2018 |
| Numatoma pirminio užbaigimo data: | 08/31/2019 |
| Numatoma studijų užbaigimo data: | 11/30/2019 |
Būklė ar liga
Intervencija / gydymas
Drug: Low CBD
Drug: High CBD
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: Low CBD Low CBD dose TN-TC11LM oral capsules (THC 2.5 mg / CBD 2.5 mg). | Drug: Low CBD Participants will start by taking 1 capsule twice daily for 1 week (5 mg THC/5 mg CBD) and increase the number of capsules as tolerated to a maximum of 10 capsules taken throughout the day by weeks 5-12 (25 mg THC/25 mg CBD total per day). |
| Experimental: High CBD High CBD dose TN-TC19LM oral capsules (THC 5 mg / CBD 45 mg). | Drug: High CBD Participants will start by taking 1 capsule once daily for 1 week (5 mg THC/45 mg CBD) and increase the number of capsules as tolerated to a maximum of 5 capsules taken throughout the day by weeks 5-12(25 mg THC/225 mg CBD total). |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. WHO toxicity scale [week 0-12]
Antrinės rezultatų priemonės
1. Change in immune cell profile [week 0-12]
2. Change in plasma inflammatory markers [week 0-12]
3. Change in proportion activated CD4 and CD8 T cell lymphocytes [week 0-12]
