Phase 4
N=4
Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV
Chronic Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT05209867 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Differentially Expressed Genes — 8.3 Differentially expressed genes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CBD oil (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Differentially Expressed Genes |
8.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05209867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.