Youth With HIV Clinical Trial
Official title:
Consequences of Marijuana Use on Inflammatory Pathways in HIV-Infected Youth
| Verified date | November 2023 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | October 15, 2021 |
| Est. primary completion date | October 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 28 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke UMC | Durham | North Carolina |
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | University of North Carolina, Chapel Hill |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of bio-marker pathways that are abnormal. | This is measured by molecular mechanism of chronic macrophage activation. | 24 months | |
| Primary | Plasma levels of sCD163 | Chi-square test will be used to compare discrete variables | 24 months | |
| Primary | Neurocognitive function as measured by Trial Making Test (TMT) | 24 months | ||
| Primary | Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate) | 24 months | ||
| Primary | Neurocognitive function as measured by Hopkins Verbal Learning Test-R | 24 months | ||
| Primary | Neurocognitive function as measured by the Brief Visuospatial Memory Test-R | 24 months | ||
| Primary | Neurocognitive function as measured by the WRAT-4 Word Reading subtest | 24 months | ||
| Primary | Neurocognitive function as measured by Activities of Daily Living Questionnaire | 24 months | ||
| Primary | Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning | 24 months | ||
| Primary | Neurocognitive function as measured by Grooved Pegboard test | 24 months | ||
| Primary | Neurocognitive function as measured by Timed Gait Test | 24 months | ||
| Primary | Neurocognitive function as measured by Verbal Fluency Test | 24 Months | ||
| Primary | Neurocognitive function as measured by Brief Symptom Inventory | 24 months | ||
| Primary | Neurocognitive function as measured by Beck Depression Inventory-II | 24 months | ||
| Primary | Neurocognitive function as measured by ASSIST (substance abuse) | 24 months | ||
| Primary | Neurocognitive function as measured by Base ATN Adherence Questions | 24 months |