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

NCT05209867 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB202101624 -AOCR41346
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammation

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

CBD Intervention

EXPERIMENTAL

Participants will self-administer CBD daily for 2 months.

Drug: CBD oil

Interventions

CBD oil DRUG

* 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

Also known as: Cannabidiol

CBD Intervention

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Consortium for Medical Marijuana Clinical Outcomes Research: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Marini S, Huber A, Cash MN, Salemi M, Cook RL, Borsa P, Mavian CN. Oral Cannabidiol Treatment Is Associated with an Anti-Inflammatory Gene Expression Signature in Myeloid Cells of People Living with HIV. Cannabis Cannabinoid Res. 2024 Aug;9(4):1028-1037. doi: 10.1089/can.2023.0139. Epub 2024 Jan 22.

  PMID: 38252549 DERIVED

Related Links

• Preprint of the study on medRxiv

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Limitations and Caveats

We processed data for individuals with different lengths of CBD exposure (2 months for two individuals; 1 month for one individual). The outcome is calculated at the single-cell level (i.e., the gene expression of each cell, from each sample, is measured), and not at the patient level. The low number of recruited patients makes impossible to draw conclusions at the patient level.

Results Point of Contact

• Title: Dr. Simone Marini
• Organization: University of Florida

simone.marini@ufl.edu

3522948951

Study Officials

• Simone Marini, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: May 1, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: December 28, 2023
• Results First Posted: December 28, 2023

Record last verified: 2023-12

Locations

US (1)