Clinical trial NCT03927053: Consequences of Marijuana Use in HIV-infected Youth
Official title: Consequences of Marijuana Use on Inflammatory Pathways in HIV-Infected Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Youth With HIV
Keywords: substance use
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2019-04-25
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 \[targeted number 10 participants\]

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

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

Primary outcomes:
measure: Number of bio-marker pathways that are abnormal.
timeFrame: 24 months
measure: Plasma levels of sCD163
timeFrame: 24 months
measure: Neurocognitive function as measured by Trial Making Test (TMT)
timeFrame: 24 months
measure: Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate)
timeFrame: 24 months
measure: Neurocognitive function as measured by Hopkins Verbal Learning Test-R
timeFrame: 24 months
measure: Neurocognitive function as measured by the Brief Visuospatial Memory Test-R
timeFrame: 24 months
measure: Neurocognitive function as measured by the WRAT-4 Word Reading subtest
timeFrame: 24 months
measure: Neurocognitive function as measured by Activities of Daily Living Questionnaire
timeFrame: 24 months
measure: Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning
timeFrame: 24 months
measure: Neurocognitive function as measured by Grooved Pegboard test
timeFrame: 24 months
measure: Neurocognitive function as measured by Timed Gait Test
timeFrame: 24 months
measure: Neurocognitive function as measured by Verbal Fluency Test
timeFrame: 24 Months
measure: Neurocognitive function as measured by Brief Symptom Inventory
timeFrame: 24 months
measure: Neurocognitive function as measured by Beck Depression Inventory-II
timeFrame: 24 months
measure: Neurocognitive function as measured by ASSIST (substance abuse)
timeFrame: 24 months
measure: Neurocognitive function as measured by Base ATN Adherence Questions
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke UMC
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John W sleasman, MD
role: PRINCIPAL_INVESTIGATOR
References: