NCT03550352

Cannabinoids in PLWHIV on Effective ART

Cannabinoids in People Living With HIV on Effective Antiretroviral Therapy: A Pilot Study to Assess Safety, Tolerability and Effect on Immune Activation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 either THC and CBD (THC 2.5 mg / CBD 2.5 mg; TN-TC11M2) vs. CBD alone (CBD 200 mg; TN-C200M2). 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-TC11M2 and TN-C200M2 oral capsules to reduce inflammation and possibly influence HIV persistence.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	TN-TC11M2 oral capsules (THC 2.5 mg/CBD 2.5 mg)	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 6 capsules taken throughout the day by weeks 5-12 (15 mg THC/15 mg CBD total per day).
DRUG	TN-C200M2 oral capsules (CBD 200 mg)	Participants will start by taking 1 capsule once daily for 1 week (200 mg CBD) and increase the number of capsules as tolerated to a maximum of 4 capsules taken throughout the day by weeks 5-12 (800 mg CBD total).

Timeline

• Start date: 2021-08-20
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2018-06-08
• Last updated: 2022-06-30

Locations

1 site across 1 country: Canada