Chronic Inflammation
Conditions
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.
Interventions
DRUGCBD 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
Sponsors
Consortium for Medical Marijuana Clinical Outcomes Research
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBD Intervention Participants will self-administer CBD daily for 2 months.
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 | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | CBD Intervention |
|---|---|
| 10x single-cell gene expression | 6553 Number of cells per patient STANDARD_DEVIATION 2111.5 |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| High-sensitivity CRP | 4.7 MG/L STANDARD_DEVIATION 4.8 |
| Procalcitonin | 0.013 NG/ML STANDARD_DEVIATION 0.006 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sedimentation Rate | 19 MM/HR STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
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).
Time frame: Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)
Population: Four individuals completed the assigned intervention. One individual completed one month only. Two individuals completed two months. A fourth individual completed two months but, after protocol and data review, the quality of the provided data was deemed not sufficient (single-cell RNA was not sequenced, gene expression not measured for that individual).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBD Intervention | Number of Differentially Expressed Genes | 8.3 Differentially expressed genes | Standard Deviation 7 |