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Consequences of Marijuana Use in HIV-infected Youth

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ClinicalTrials.gov Identifier: NCT03927053
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Duke University

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

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


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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
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Marijuana

Group/Cohort
HIV infected youth who use marijuana only
HIV infected youth who use tobacco only
HIV infected youth who use tobacco and marijuana
HIV infected youth with no substance use



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 .


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927053


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

Locations
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United States, North Carolina
Duke UMC Recruiting
Durham, North Carolina, United States, 27710
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Joan Wilson, BSN    919-681-8739    joan.wilson@duke.edu   
Principal Investigator: John W Sleasman, MD,         
Sponsors and Collaborators
Duke University
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: John W sleasman, MD Duke University

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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: October 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Marijuana Use
Substance-Related Disorders
Mental Disorders