Effects of cannabis on the microbiome and inflammation in HIV
Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV
This study is testing how cannabis compounds THC and CBD affect gut health and inflammation in people living with HIV.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05514899 on ClinicalTrials.gov |
What this trial studies
This study investigates how cannabis use, specifically THC and CBD, affects the microbiome and neuroinflammation in individuals with HIV. Participants will be randomly assigned to receive either THC or CBD for 14 days, followed by a crossover to the other treatment after a washout period. The study aims to characterize the gut microbiota and endocannabinoid system in response to these cannabinoids, while also assessing inflammation patterns in blood and cerebrospinal fluid. The research will involve physical examinations, blood tests, and fecal shotgun metagenomic sequencing to monitor safety and measure treatment effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 to 70 with HIV who are virally suppressed and have a normal CD4 count.
Not a fit: Patients with significant history of ART regimen adherence challenges or those with advanced HIV stages may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for treating neuroinflammation and improving gut health in patients with HIV.
How similar studies have performed: While there is emerging interest in the effects of cannabinoids on inflammation, this specific approach focusing on the microbiome in HIV is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
1. Aged 21 to 70 years old 2. Possess the capacity to provide informed consent to a set of neuromedical assessment procedures. 3. Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope) 4. No or low cannabis use in the past 2 weeks, defined as no cannabis exposure or use or use limited to only once in the past 2 weeks. 5. Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention 6. Individuals with HIV must meet the following criteria 1. Virally suppressed on stable ART for at least 6 months and have no more than 1 prior event of virologic failure (i.e., required change in ARTs due to virologic failure) 2. Stage 1 or 2 infection 3. Have a "normal" CD4 count defined as ≥350 cells/microliter 4. No significant history of ART regimen adherence challenges 7. Ability to adhere to the study visit schedule. Exclusion Criteria: 1. Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days; 2. Significant cognitive impairment such as Dementia, including Alzheimer's disease 3. Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial; refusal to maintain highly effective contraceptive methods (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) during the study for persons of child-bearing potential or those with partners of child-bearing potential 4. Evidence of moderately or worse compromised liver or kidney function, including moderate (Child-Hugh B) or severe (Child-Hugh C) hepatic impairment and AST and ALT above ULN and total bilirubin above ULN; 5. Evidence of significant cardiovascular risk, resting heart rate \<50 or \>110 beats per minute, uncontrolled hypertension (systolic blood pressure \<80 or \>140 mmHg; diastolic blood pressure \<50 or \>90 mmHg), history of myocardial infarction, congestive heart failure, or arrhythmia); 6. Evidence of chronic pulmonary disease requiring supplemental oxygen; 7. Active, recent, or remote medical history of hepatobiliary-related illness, including elevated transaminase levels above 3 times the upper limit of normal accompanied by elevations in total bilirubin above 2 times the upper limit of normal at screening; 8. Insulin dependent diabetics 9. Allergy to the study drugs or any of their constituents including sesame 10. Use of medications with absolute contraindicated or potential significant interactions 11. Use of sedating medications 12. Weighing less than 60 kg at screening to minimize the risk of elevated transaminases as a result of exposure to cannabidiol; 13. Active, uncontrolled psychiatric disorder with psychotic features, severe depression, or suicidality; Participants will be excluded if they have had a history of suicide attempt, recent suicidal ideation or behavior as indexed by their Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression). 14. Neurologic disorder that could compromise interpretation of study findings, including uncontrolled seizure disorder (active seizures within the past 3 months), multiple sclerosis, Parkinson's disease, Alzheimer's disease, and recent (past 3 months) cerebral infarction or hemorrhage with neurological sequelae.
Where this trial is running
San Diego, California
- HIV Neurobehavioral Research Program (HNRP) — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Ronald J Ellis, MD, PhD — UC San Diego
- Study coordinator: Roberto Gallardo
- Email: hnrprecruitment@ucsd.edu
- Phone: 619-543-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.