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Consequences of Marijuana Use in HIV-infected Youth

  • Clinicaltrials.gov identifier

    NCT03927053

  • Recruitment Status

    Recruiting

  • First Posted

    April 25, 2019

  • Last update posted

    May 7, 2020

Study Description

Brief summary:

Proposed study focuses on Youth With HIV (YWH) recruited from the University of North Carolina using a cross sectional assessment of blood samples, clinical, demographic, behavioral, [including substance use and frequency], and neurocognitive data will be evaluated from YWH treated before CD4 T cell decline.

  • Condition or Disease:Youth With HIV
  • Intervention/Treatment:
  • Phase: N/A

Detailed Description

The long-term goal for the proposed research is to apply a systems biology approach to discover evidence that provides the basis for understanding the complex and at times conflicting roles for marijuana in chronic inflammation in HIV-infected youth. To achieve the goal, a systems biology approach with two aims is designed: Aim 1. To identify inflammatory immune pathways perturbed by recreational marijuana with or without concomitant use of tobacco products by applying a deep sequencing approach to define global transcriptome of peripheral blood cells from HIV-infected virally suppressed youth. Aim 2. To develop biomarker profiles associated with pro- or anti-inflammatory pathways perturbed by marijuana and to discover biomarker profiles linked to neurocognitive impairment that are impacted by marijuana and tobacco use by YWH

Study Design

  • Study Type: Observational
  • Estimated Enrollment: 60 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Consequences of Marijuana Use on Inflammatory Pathways in HIV-Infected Youth
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: March 2021

Outcome Measures

  • Primary Outcome Measures: 1. Number of bio-marker pathways that are abnormal. [ Time Frame: 24 months ]
    This is measured by molecular mechanism of chronic macrophage activation.
  • 2. Plasma levels of sCD163 [ Time Frame: 24 months ]
    Chi-square test will be used to compare discrete variables
  • 3. Neurocognitive function as measured by Trial Making Test (TMT) [ Time Frame: 24 months ]
  • 4. Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate) [ Time Frame: 24 months ]
  • 5. Neurocognitive function as measured by Hopkins Verbal Learning Test-R [ Time Frame: 24 months ]
  • 6. Neurocognitive function as measured by the Brief Visuospatial Memory Test-R [ Time Frame: 24 months ]
  • 7. Neurocognitive function as measured by the WRAT-4 Word Reading subtest [ Time Frame: 24 months ]
  • 8. Neurocognitive function as measured by Activities of Daily Living Questionnaire [ Time Frame: 24 months ]
  • 9. Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning [ Time Frame: 24 months ]
  • 10. Neurocognitive function as measured by Grooved Pegboard test [ Time Frame: 24 months ]
  • 11. Neurocognitive function as measured by Timed Gait Test [ Time Frame: 24 months ]
  • 12. Neurocognitive function as measured by Verbal Fluency Test [ Time Frame: 24 Months ]
  • 13. Neurocognitive function as measured by Brief Symptom Inventory [ Time Frame: 24 months ]
  • 14. Neurocognitive function as measured by Beck Depression Inventory-II [ Time Frame: 24 months ]
  • 15. Neurocognitive function as measured by ASSIST (substance abuse) [ Time Frame: 24 months ]
  • 16. Neurocognitive function as measured by Base ATN Adherence Questions [ Time Frame: 24 months ]
  • Biospecimen Retention: Samples Without DNA

    plasma biomarker measurements, toxicology measurements, proteomics studies, transcriptome analyses, flow cytometric analysis and storage. Cryopreserved peripheral blood cells, serum and plasma .

Eligibility Criteria

  • Ages Eligible for Study: 21 to 28 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Enrollment will consist of approximately 61 HIV-infected youth meeting the below entry criteria who are receiving antiretroviral therapy with undetectable viral levels at the time of entry (based on viral load assay within 1 year of enrollment) Recruitment will include Youth Age 21-28 - Youth who use marijuana only [targeted number 20 participants] - Youth who use tobacco products only [targeted number 24 participants] - Youth who use marijuana and tobacco [targeted number 7 participants] - Youth who do not use substances [targeted number 10 participants]

Criteria

Inclusion Criteria:

- Age 21 years 0 days - less than28 years 364 days

- Currently treated with stable ART and no ART changes for >6months.

- Willingness to participate in CASI questionnaire of self-reported substance use

- Documented behavioral transmission of HIV infection based on CLIA approved HIV
antibody/antigen based testing method in medical record -HIV diagnosis greater than or
equal to years. Viral load LESS THAN 50 COPIES/ML for the past 6 months. --

Patients may have had single blips in viral load to greater than 50 but less than 1000
copies/ml within the year prior to screening.

- Current Substance profile by chart review or phone screening:

- Marijuana use defined as marijuana use by any route at least 3 times per week in the
absence of tobacco. N= 20.

- Tobacco use only based on report of regular (at least 3 times per week smoking). N=24

- Tobacco plus marijuana use defined as regular smoking and marijuana (at least 3 times
per week) N =7

- No substance use of any type (alcohol, tobacco, marijuana or other recreational drugs
in the past 90 days). N = 10

- Able to provide written informed consent in English and to adhere to protocol schedule

Exclusion Criteria:

- History of AIDS defining illness

- Pregnancy at any time during the study

- Use of substances that would interfere with the ability to complete the study

- History of significant cognitive or motor impairment or other chronic condition that
would interfere with the ability to complete the study and impact neurocognitive
testing

- Acute psychiatric symptoms (e.g. suicidality, mania, psychosis or severe depression)

- Other neurological disorder (e.g. multiple sclerosis, seizure disorder, etc.)
requiring ongoing treatment or active outpatient evaluation

- Severe mental illness (requiring antipsychotic or mood stabilizing medications and/or
inpatient hospitalization in past year)

- History of CNS infection (AIDS opportunistic (e.g. toxoplasmosis) or non-opportunistic
(bacterial meningitis) with lasting or permanent neurological sequelae)

- Underlying and/or uncontrolled medical illnesses that may result in chronic
inflammation , (e.g. SLE or autoimmune disease) as determined by the PI

- Nursing mothers

- Unable to read and write in English

Contacts and Locations

Contacts

Contact: Joan Wilson, RN 929-681-8739 joan.wilson@duke.edu

Locations

United States, North Carolina
Duke UMC
Durham

United States, North Carolina
Duke University Medical Center
Durham

Sponsors and Collaborators

Duke University

University of North Carolina, Chapel Hill

Investigators

Principal Investigator: John W sleasman, MD Duke University

More Information

  • Responsible Party: Duke University
  • ClinicalTrials.gov Identifier: NCT03927053 History of Changes
  • Other Study ID Numbers: Pro00100780
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: May 7, 2020
  • Last Verified: May 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Duke University: substance use
  • Additional relevant MeSH terms: Marijuana Use