Consequences of Marijuana Use in HIV-infected Youth
Raktažodžiai
Santrauka
apibūdinimas
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
Datos
| Paskutinį kartą patikrinta: | 04/30/2020 |
| Pirmasis pateikimas: | 04/22/2019 |
| Numatytas registravimas pateiktas: | 04/22/2019 |
| Pirmas paskelbtas: | 04/24/2019 |
| Paskutinis atnaujinimas pateiktas: | 05/05/2020 |
| Paskutinis atnaujinimas paskelbtas: | 05/06/2020 |
| Faktinė studijų pradžios data: | 10/30/2019 |
| Numatoma pirminio užbaigimo data: | 03/29/2021 |
| Numatoma studijų užbaigimo data: | 03/29/2021 |
Būklė ar liga
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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 |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 21 Years Į 21 Years |
| Tinkamos studijoms lytys | All |
| Mėginių ėmimo metodas | Non-Probability Sample |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Number of bio-marker pathways that are abnormal. [24 months]
2. Plasma levels of sCD163 [24 months]
3. Neurocognitive function as measured by Trial Making Test (TMT) [24 months]
4. Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate) [24 months]
5. Neurocognitive function as measured by Hopkins Verbal Learning Test-R [24 months]
6. Neurocognitive function as measured by the Brief Visuospatial Memory Test-R [24 months]
7. Neurocognitive function as measured by the WRAT-4 Word Reading subtest [24 months]
8. Neurocognitive function as measured by Activities of Daily Living Questionnaire [24 months]
9. Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning [24 months]
10. Neurocognitive function as measured by Grooved Pegboard test [24 months]
11. Neurocognitive function as measured by Timed Gait Test [24 months]
12. Neurocognitive function as measured by Verbal Fluency Test [24 Months]
13. Neurocognitive function as measured by Brief Symptom Inventory [24 months]
14. Neurocognitive function as measured by Beck Depression Inventory-II [24 months]
15. Neurocognitive function as measured by ASSIST (substance abuse) [24 months]
16. Neurocognitive function as measured by Base ATN Adherence Questions [24 months]
