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

Phase 4

Completed

• Conditions: Chronic Inflammation
• Interventions: Drug: CBD oil

• Registration Number: NCT05209867
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-01-27
• Study Start: 2022-05-01
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Results First Submitted: 2023-10-24
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Results First Posted: 2023-12-28
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBD Intervention	CBD oil	Participants will self-administer CBD daily for 2 months.

Primary Outcome Measures

Name	Time	Method
Number of Differentially Expressed Genes	Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)	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).

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States