Consequences of Marijuana Use in HIV-infected Youth

NCT ID: NCT03927053

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2021-10-15

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

Conditions

Youth With HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV infected youth who use marijuana only

No interventions assigned to this group

HIV infected youth who use tobacco only

No interventions assigned to this group

HIV infected youth who use tobacco and marijuana

No interventions assigned to this group

HIV infected youth with no substance use

No interventions assigned to this group

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John W sleasman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke UMC

Durham, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00100780

Identifier Type: -

Identifier Source: org_study_id