Consequences of Marijuana Use in HIV-infected Youth

NCT03927053 | Completed

• 1 other identifier: Pro00100780
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Youth With HIV

Keywords

substance use

Outcome Measures

Primary Outcomes (16)

• Number of bio-marker pathways that are abnormal.

  This is measured by molecular mechanism of chronic macrophage activation.

  24 months

• Plasma levels of sCD163

  Chi-square test will be used to compare discrete variables

  24 months

• Neurocognitive function as measured by Trial Making Test (TMT)

  24 months

• Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate)

  24 months

• Neurocognitive function as measured by Hopkins Verbal Learning Test-R

  24 months

• Neurocognitive function as measured by the Brief Visuospatial Memory Test-R

  24 months

• Neurocognitive function as measured by the WRAT-4 Word Reading subtest

  24 months

• Neurocognitive function as measured by Activities of Daily Living Questionnaire

  24 months

• Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning

  24 months

• Neurocognitive function as measured by Grooved Pegboard test

  24 months

• Neurocognitive function as measured by Timed Gait Test

  24 months

• Neurocognitive function as measured by Verbal Fluency Test

  24 Months

• Neurocognitive function as measured by Brief Symptom Inventory

  24 months

• Neurocognitive function as measured by Beck Depression Inventory-II

  24 months

• Neurocognitive function as measured by ASSIST (substance abuse)

  24 months

• Neurocognitive function as measured by Base ATN Adherence Questions

  24 months

Study Arms (4)

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

Eligibility Criteria

• Age: 21 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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 \[targeted number 10 participants\]

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

Duke UMC

Durham, North Carolina, 27710, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

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 .

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• John W sleasman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: October 31, 2019
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)