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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 : May 7, 2020
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date April 23, 2019
First Posted Date April 25, 2019
Last Update Posted Date May 7, 2020
Actual Study Start Date October 31, 2019
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2019)
  • Number of bio-marker pathways that are abnormal. [ Time Frame: 24 months ]
    This is measured by molecular mechanism of chronic macrophage activation.
  • Plasma levels of sCD163 [ Time Frame: 24 months ]
    Chi-square test will be used to compare discrete variables
  • Neurocognitive function as measured by Trial Making Test (TMT) [ Time Frame: 24 months ]
  • Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate) [ Time Frame: 24 months ]
  • Neurocognitive function as measured by Hopkins Verbal Learning Test-R [ Time Frame: 24 months ]
  • Neurocognitive function as measured by the Brief Visuospatial Memory Test-R [ Time Frame: 24 months ]
  • Neurocognitive function as measured by the WRAT-4 Word Reading subtest [ Time Frame: 24 months ]
  • Neurocognitive function as measured by Activities of Daily Living Questionnaire [ Time Frame: 24 months ]
  • Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning [ Time Frame: 24 months ]
  • Neurocognitive function as measured by Grooved Pegboard test [ Time Frame: 24 months ]
  • Neurocognitive function as measured by Timed Gait Test [ Time Frame: 24 months ]
  • Neurocognitive function as measured by Verbal Fluency Test [ Time Frame: 24 Months ]
  • Neurocognitive function as measured by Brief Symptom Inventory [ Time Frame: 24 months ]
  • Neurocognitive function as measured by Beck Depression Inventory-II [ Time Frame: 24 months ]
  • Neurocognitive function as measured by ASSIST (substance abuse) [ Time Frame: 24 months ]
  • Neurocognitive function as measured by Base ATN Adherence Questions [ Time Frame: 24 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Consequences of Marijuana Use in HIV-infected Youth
Official Title Consequences of Marijuana Use on Inflammatory Pathways in HIV-Infected Youth
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
plasma biomarker measurements, toxicology measurements, proteomics studies, transcriptome analyses, flow cytometric analysis and storage. Cryopreserved peripheral blood cells, serum and plasma .
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]
Condition Youth With HIV
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 30, 2021
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 28 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Joan Wilson, RN 929-681-8739 joan.wilson@duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03927053
Other Study ID Numbers Pro00100780
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators University of North Carolina, Chapel Hill
Investigators
Principal Investigator: John W sleasman, MD Duke University
PRS Account Duke University
Verification Date May 2020