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

University of Florida

Status and phase: Completed; Phase 4

Conditions: Chronic Inflammation

Treatments: Drug: CBD oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05209867

IRB202101624 -A

OCR41346 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

CBD Intervention

Experimental group

Description:

Participants will self-administer CBD daily for 2 months.

Treatment:

Drug: CBD oil