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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV

Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV (NCT05514899) is a Phase 2 interventional studying HIV and Cannabis, sponsored by University of California, San Diego. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against HIV and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 90 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused HIV subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

1. Aged 21 to 70 years old 2. Possess the capacity to provide willing to sign a consent form 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. Who Should NOT Join This Trial: 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

THC

THC capsule

DRUG

CBD

oral solution

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

HIV Neurobehavioral Research Program (HNRP)
San Diego, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05514899), the sponsor (University of California, San Diego), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05514899 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05514899?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05514899?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05514899. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05514899. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.