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Consequences of Marijuana Use in HIV-infected Youth

  • identifier


  • Recruitment Status


  • 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]


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

- 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


Contact: Joan Wilson, RN 929-681-8739


United States, North Carolina
Duke UMC

United States, North Carolina
Duke University Medical Center

Sponsors and Collaborators

Duke University

University of North Carolina, Chapel Hill


Principal Investigator: John W sleasman, MD Duke University

More Information

  • Responsible Party: Duke University
  • 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

  • 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