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HIV InfectionsPhase 2NCT03550352

Cannabinoids in PLWHIV on Effective ART

A Phase 2 study testing TN-TC11M2 oral capsules (THC 2.5 mg/CBD 2.5 mg) and TN-C200M2 oral capsules (CBD 200 mg) in people with HIV Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
HIV Infections
What is being tested?
TN-TC11M2 oral capsules (THC 2.5 mg/CBD 2.5 mg) and TN-C200M2 oral capsules (CBD 200 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
20 Aug 2021to 31 May 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • 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)
  • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) or alkaline phosphatase >2.5 x upper limit of normal (ULN)
  • Active AIDS event in the last month as determined by the treating physician
  • Renal dysfunction
  • Unstable psychological or psychiatric condition as determined by the treating physician
  • Holding employment which requires operation of heavy machinery or which requires undergoing drug screening (i.e., pilot or police officer)
  • Concurrent use within the past 8 week of anabolic hormones, prednisone, IL-2 or other agents known to alter immune function.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

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.

Read the 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
Being tested
TN-TC11M2 oral capsules (THC 2.5 mg/CBD 2.5 mg), TN-C200M2 oral capsules (CBD 200 mg)
Keywords
HIV, Cannabinoids, HIV reservoir, Microbiome, CBD, THC, Inflammation, Immune activation
Medical subject headings
HIV Infections, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • 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).

Study groups in NCT03550352
Study groupRoleWhat they receive
1) THC and CBD combinedExperimentalTN-TC11M2 oral capsules (THC 2.5 mg / CBD 2.5 mg)
Receives: Drug: TN-TC11M2 oral capsules (THC 2.5 mg/CBD 2.5 mg)
2) CBD aloneExperimentalTN-C200M2 oral capsules (CBD 200 mg)
Receives: Drug: TN-C200M2 oral capsules (CBD 200 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: week 0-12

Secondary outcomes (3)

  1. 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

    Measured: week 0-12

  2. Change in plasma inflammatory markers

    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

    Measured: week 0-12

  3. 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

    Measured: week 0-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2018
  2. Study start20 Aug 2021
  3. Primary completion31 May 2022
  4. Study completion31 May 2022

Why it stopped: expiration of study product; end of study product availability

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03550352
Sponsor's protocol ID
CTNPT 028
Other IDs
2018-4336
Status last verified
Jun 2022
First submitted
23 May 2018
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30659041

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TN-TC11M2 oral capsules (THC 2.5 mg/CBD 2.5 mg) and TN-C200M2 oral capsules (CBD 200 mg) in people with HIV Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: expiration of study product; end of study product availability). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WHO toxicity scale (time frame: week 0-12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03550352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.

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