Consequences of Marijuana Use in HIV-infected Youth

Completed

Conditions studied: Youth With HIV

In brief

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.

Key facts

Study ID

NCT03927053

Run by

Duke University

People needed

21

Starts

2019-10-31

Expected to finish

2021-10-15

Last updated by the study team

2023-11-13

Who can join

Age: 21 and older, up to 28. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Duke UMC — Durham, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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