Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV

Study Overview
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Brief Summary
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People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH. The investigators propose to study the effects of CBD on inflammation in PLWH, and establish the molecular role of different immune cells in this process. The investigators plan to use single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five persons with HIV who will provide blood samples before and after taking CBD.

Official Title
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CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level

Conditions
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Chronic Inflammation

Intervention / Treatment
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* Drug: CBD oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willingness to take CBD and to participate in follow up for two months Older than 21 and younger than 60 Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count <350cells/ml) Exclusion Criteria: Conditions/medications that may impair the immune response, e.g., rheumatoid arthritis, cancer, diabetes, chronic infections, CAD (Cold agglutinin disease), cellulitis, autoimmune diseases such as lupus, sarcoidosis All medications that may affect inflammation such as aspirin, steroids, statins; CD4 count <350cells/ml), pregnancy, and current marijuana or CBD use (urine drug screen) UF(University of Florida)/Shands staff and students will not be considered for enrollment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBD Intervention<br>Participants will self-administer CBD daily for 2 months. | Drug: CBD oil<br>* Each participant will be provided two 30mL(Milliliters) bottles (2000mg CBD per bottle) with a syringe dropper during their initial (baseline) visit with instructions to administer the solution under the tongue (0.5 cc  1/2 dropper) twice per day (BID) 8-12 hours apart (morning and evening) at the prescribed daily dosage (63mg/day). The investigators plan to collect samples from five patients over three time points: baseline (no CBD), and after one and two months of CBD-administration<br>* Other names: Cannabidiol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Differentially Expressed Genes | Number of genes with a significant fold change before/after CBD in PBMCs (Peripheral Blood Mononuclear Cells) related to inflammation genes, calculated before and after CBD treatment (baseline and 1 month for 1 participant, 2 months for 2 participants). | Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals) |