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Cannabinoids in PLWHIV on Effective ART

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ClinicalTrials.gov Identifier: NCT03550352
Recruitment Status : Unknown
Verified June 2018 by Cecilia Costiniuk, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Tilray
CIHR Canadian HIV Trials Network
Université du Québec a Montréal
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Cecilia Costiniuk, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 8, 2018
Last Update Posted Date June 8, 2018
Estimated Study Start Date  ICMJE August 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabinoids in PLWHIV on Effective ART
Official Title  ICMJE Cannabinoids in People Living With HIV on Effective Antiretroviral Therapy: A Pilot Study to Assess Safety, Tolerability and Effect on Immune Activation
Brief Summary The purpose of this pilot study is to assess feasibility and to examine whether oral cannabinoids (capsules containing Δ9-tetrahydrocannabinol and cannabidiol in 2 different ratios) 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Low CBD dose TN-CT11LM oral capsules(THC2.5 mg/CBD2.5 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 10 capsules taken throughout the day by weeks 5-12 (25 mg THC/25 mg CBD total per day).
  • Drug: High CBD dose TN-TC19LM oral capsules (THC 5 mg / CBD 45 mg)
    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).
Study Arms  ICMJE
  • Experimental: Low CBD
    Low CBD dose TN-TC11LM oral capsules (THC 2.5 mg / CBD 2.5 mg).
    Intervention: Drug: Low CBD dose TN-CT11LM oral capsules(THC2.5 mg/CBD2.5 mg)
  • Experimental: High CBD
    High CBD dose TN-TC19LM oral capsules (THC 5 mg / CBD 45 mg).
    Intervention: Drug: High CBD dose TN-TC19LM oral capsules (THC 5 mg / CBD 45 mg)
Publications * Costiniuk CT, Saneei Z, Routy JP, Margolese S, Mandarino E, Singer J, Lebouché 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 6, 2018)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03550352
Other Study ID Numbers  ICMJE CTNPT 028
2018-4336 ( Registry Identifier: MUHC Research Ethics Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cecilia Costiniuk, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE
  • Tilray
  • CIHR Canadian HIV Trials Network
  • Université du Québec a Montréal
  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators  ICMJE
Principal Investigator: Cecilia Costiniuk, MD, MSc McGill University Health Centre/Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP