NCT05514899 Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
| NCT ID | NCT05514899 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Diego |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2023-09-01 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Ronald J Ellis, MD, PhD
PRINCIPAL INVESTIGATOR
UC San Diego
Frequently Asked Questions
Who can join the NCT05514899 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05514899 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05514899 currently recruiting?
Yes, NCT05514899 is actively recruiting participants. Contact the research team at hnrprecruitment@ucsd.edu for enrollment information.
Where is the NCT05514899 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT05514899 clinical trial?
NCT05514899 is sponsored by University of California, San Diego. The principal investigator is Ronald J Ellis, MD, PhD at UC San Diego. The trial plans to enroll 90 participants.
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