Actively Recruiting
Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
Led by University of California, San Diego · Updated on 2026-05-01
90
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.
CONDITIONS
Official Title
Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 to 70 years old
- Able to provide informed consent for neuromedical assessments
- Cannabis use at least once in the past 5 years without major adverse effects
- No or low cannabis use in the past 2 weeks (no use or only once)
- Willing to abstain from cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention
- For people with HIV: virally suppressed on stable ART for at least 6 months with no more than 1 prior virologic failure
- For people with HIV: stage 1 or 2 infection
- For people with HIV: normal CD4 count (≥350 cells/microliter)
- For people with HIV: no significant history of ART adherence problems
- Able to follow the study visit schedule
You will not qualify if you...
- Substance use disorder other than cannabis in the last 30 days
- Significant cognitive impairment such as dementia or Alzheimer's disease
- Pregnant, breastfeeding, or unwilling to use highly effective contraception during the trial
- Moderate or severe liver or kidney problems, including abnormal liver tests
- Significant cardiovascular risk or heart conditions
- Chronic lung disease needing supplemental oxygen
- History of serious hepatobiliary illness with elevated liver enzymes
- Insulin-dependent diabetes
- Allergy to study drugs or ingredients including sesame
- Use of medications with major interactions or sedating drugs
- Weighing less than 60 kg at screening
- Active uncontrolled psychiatric disorders with psychotic features, severe depression, or suicidality
- Neurologic disorders that affect study results, including recent seizures, multiple sclerosis, Parkinson's, Alzheimer's, or recent stroke with lasting effects
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
HIV Neurobehavioral Research Program (HNRP)
San Diego, California, United States, 92103
Actively Recruiting
Research Team
R
Roberto Gallardo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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