Clinical trial

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

NCT05209867

Name

IRB202101624 -A

Description

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.

Trial arms

Trial start

2022-05-01

Estimated PCD

2022-12-12

Trial end

2022-12-12

Status

Completed

Phase

Early phase I

Treatment

CBD oil

* 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

Arms:

CBD Intervention

Other names:

Cannabidiol

Size

Primary endpoint

Number of Differentially Expressed Genes

Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

Updated at

2023-12-28

1 organization

1 product

1 indication

Organization

University of Florida

Product

CBD oil

Indication

Chronic Inflammation