Effects of cannabis on the microbiome and inflammation in HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.