NCT05514899RecruitingPhase 2
Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 22 Aug 2022
- Start date
- 1 Sept 2023
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- University of California, San Diego
- Diseases
- HIV
- NCT number
- NCT05514899
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 1 Sept 2023 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Use of medications with absolute contraindicated or potential significant interactions
- Use of sedating medications
Other illness
- Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;
- Significant cognitive impairment such as Dementia, including Alzheimer's disease
- 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);
- Evidence of chronic pulmonary disease requiring supplemental oxygen;
- Allergy to the study drugs or any of their constituents including sesame
- 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).
- 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.
Lab values
- 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;
- 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;
- Weighing less than 60 kg at screening to minimize the risk of elevated transaminases as a result of exposure to cannabidiol;
Other
- Insulin dependent diabetics
Criteria the registry did not label
- Aged 21 to 70 years old
- Possess the capacity to provide informed consent to a set of neuromedical assessment procedures.
- Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope)
- 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.
- Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention
- Individuals with HIV must meet the following criteria
- 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)
- Stage 1 or 2 infection
- Have a "normal" CD4 count defined as ≥350 cells/microliter
- No significant history of ART regimen adherence challenges
- Ability to adhere to the study visit schedule.
Age in the registry: 21 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HIV Neurobehavioral Research Program (HNRP) Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.