Cannabinoids in PLWHIV on Effective ART

NCT03550352 | Terminated Phase 2 DMC

• 2 other identifiers: CTNPT 0282018-4336
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

HIV; Cannabinoids; HIV reservoir; Microbiome; CBD; THC; Inflammation; Immune activation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in immune cell profile

  week 0-12

• Change in plasma inflammatory markers

  week 0-12

• Change in proportion activated CD4 and CD8 T cell lymphocytes

  week 0-12

Study Arms (2)

1) THC and CBD combined

EXPERIMENTAL

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)

2) CBD alone

EXPERIMENTAL

TN-C200M2 oral capsules (CBD 200 mg)

Drug: TN-C200M2 oral capsules (CBD 200 mg)

Interventions

TN-TC11M2 oral capsules (THC 2.5 mg/CBD 2.5 mg) DRUG

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).

1) THC and CBD combined

TN-C200M2 oral capsules (CBD 200 mg) DRUG

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).

2) CBD alone

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Documented HIV infection by Western Blot, EIA assays or viral load assays
• Male or female, Aged 18 or older
• Viral load \<40 copies/ml for at least 3 years
• On ART for at least 3 years
• No cannabinoid use for at least 1 month prior to enrolment with negative baseline cannabinoid screen
• Able to communicate adequately in either French or English
• Able and willing to provide written informed consent prior to enrolment including access to relevant medical records

You may not qualify if:

• Using cannabinoid-containing products outside of the study or within 4 weeks of study commencement
• 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.
• Enrolled in a separate study involving administration of medication, vitamin, supplement or herbal product.
• Active intravenous drug users
• Active substance dependence
• Prior history of hypersensitivity to cannabis or cannabis-containing products
• Known or suspected allergy to sunflower lecithin oil
• Active opportunistic infection or malignant condition
• Unintentional weight loss of 10 % or more of body weight in the last 6 months
• Unstable angina or acute cardiac event in the past year
• Active psychiatric disorder or history of psychiatric depression (other than mild depression or anxiety); On antipsychotic medication
• Known or suspected family history of schizophrenia or severe personality disorder
• Serious cardiovascular disease such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or severe heart failure
• Anemia (Hemoglobin \<100 g/L)
• Active liver disease or unexplained persistent elevations of serum transaminases

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Tilray: collaborator
• CIHR Canadian HIV Trials Network: collaborator
• Université du Québec a Montréal: collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Chronic Viral Illnesses Service, McGill University Health Centre-Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• Costiniuk CT, Saneei Z, Routy JP, Margolese S, Mandarino E, Singer J, Lebouche B, Cox J, Szabo J, Brouillette MJ, Klein MB, Chomont N, Jenabian MA. Oral cannabinoids in people living with HIV on effective antiretroviral therapy: CTN PT028-study protocol for a pilot randomised trial to assess safety, tolerability and effect on immune activation. BMJ Open. 2019 Jan 17;9(1):e024793. doi: 10.1136/bmjopen-2018-024793.

  PMID: 30659041 DERIVED

MeSH Terms

Conditions

HIV Infections; Inflammation

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Cecilia Costiniuk, MD, MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCPC, Associate Professor

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 8, 2018
• Study Start: August 20, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

CA (1)