Cannabinoids in PLWHIV on Effective ART
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03550352|
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : August 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: TN-TC11M2 oral capsules (THC 2.5 mg/CBD 2.5 mg) Drug: TN-C200M2 oral capsules (CBD 200 mg)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cannabinoids in People Living With HIV on Effective Antiretroviral Therapy: A Pilot Study to Assess Safety, Tolerability and Effect on Immune Activation|
|Estimated Study Start Date :||August 15, 2021|
|Estimated Primary Completion Date :||August 15, 2022|
|Estimated Study Completion Date :||August 15, 2022|
Experimental: 1) THC and CBD combined
TN-TC11M2 oral capsules (THC 2.5 mg / CBD 2.5 mg)
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).
Experimental: 2) CBD alone
TN-C200M2 oral capsules (CBD 200 mg)
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).
- WHO toxicity scale [ Time Frame: week 0-12 ]
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)
- Change in immune cell profile [ Time Frame: week 0-12 ]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
- Change in plasma inflammatory markers [ Time Frame: week 0-12 ]Change in plasma inflammatory markers from week 0 to week 12 Change in concentration of plasma inflammatory markers (interferon-α, interleukin-1β, interleukin-6, interleukin-10, interleukin-17, Transforming Growth Factor-β, interferon-gamma-induced protein-10, d-dimer, C-reactive protein, lipopolysaccharide and soluble CD14) from week 0 to week 12
- Change in proportion activated CD4 and CD8 T cell lymphocytes [ Time Frame: week 0-12 ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550352
|Contact: Cecilia Costiniuk, MD, MScemail@example.com|
|Contact: Judy Needham, PhD||604-682-2344 ext firstname.lastname@example.org|
|Chronic Viral Illnesses Service, McGill University Health Centre-Glen Site|
|Montreal, Quebec, Canada, H4A 3J1|
|Contact: Cecilia Costiniuk, MD,MSc 514-843-2090 email@example.com|
|Contact: Tara Mabanga, MSc 514-934-1934 ext 42697 firstname.lastname@example.org|
|Principal Investigator:||Cecilia Costiniuk, MD, MSc||McGill University Health Centre/Research Institute of the McGill University Health Centre|