HIVPhase 2CAMINCT05514899
Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
A Phase 2 study testing THC and CBD in people with HIV and Cannabis, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- What is being tested?
- THC and CBD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
- 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
- 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;
- 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;
Show all 14Show fewer
- 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;
- Insulin dependent diabetics
- Allergy to the study drugs or any of their constituents including sesame
- Use of medications with absolute contraindicated or potential significant interactions
- Use of sedating medications
- Weighing less than 60 kg at screening to minimize the risk of elevated transaminases as a result of exposure to cannabidiol;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HIV Neurobehavioral Research Program (HNRP)
San Diego, California, 92103
Roberto Gallardo, 619-543-5000, hnrprecruitment@ucsd.edu
Ronald J Ellis, MD, PhD
About this study
Official title: Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV
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.
Read the detailed description
This project will characterize the microbiome and endocannabinoid system (ECS) in people with HIV (PWH) and how they relate to neuroinflammation and blood-brain barrier (BBB) function. The study hypothesizes that pathogenic alterations in the gut microbiota (dysbiosis) and impaired gut barrier integrity (leaky gut) are mediators between the ECS, neuroinflammation and BBB dysfunction in HIV. The major goals are to (1) characterize the gut microbiota and ECS in response to exogenous cannabinoid exposure in both PWH and people without HIV (PWoH); (2) characterize patterns of HIV-associated inflammation (innate, adaptive, T-cell, B-cell) in blood and cerebrospinal fluid (CSF) in response to controlled cannabis exposure; (3) assess effects of cannabinoid exposure on these patterns and how they are mediated through changes in the ECS, gut microbiota and gut barrier function. The investigators will perform a clinical trial of 50 PWH and 50 PWoH exposed in a randomized, cross-over fashion to 14 days each of oral THC and CBD to determine if treatment with either phytocannabinoid reduces inflammation and improves gut function. The experimental approach will use fecal shotgun metagenomic sequencing to characterize the gut microbiome, with particular attention to aerotolerant bacteria, pro-inflammatory species, Prevotella spp., Bifidobacterium and Bacteroides spp. and butyrate-producing bacteria. We will evaluate how the microbiota and leaky gut relate to neuroinflammation and impaired BBB function, the latter potentially leading to increased central nervous system (CNS) exposure to microbially-produced pro-inflammatory ligands. The rationale for the study is that virologic suppression on antiretroviral therapy (ART) does not normalize gut lymphoid tissue cluster of differentiation 4 (CD4)+ T cell depletion, leaky gut, dysbiosis, chronic gut inflammation, and microbial antigen translocation (MAT). These alterations ultimately drive systemic and CNS inflammation. Compromised gut barrier function due to altered tight junctions, apoptosis and reduced epithelial cell proliferation and repair render PWH susceptible to increased tissue exposure to pro-inflammatory ligands produced by gut microbiota and are important in HIV neuropathogenesis. Of particular relevance here are recent findings that the ECS in the large intestine interacts with the gut microbiota to regulate epithelial barrier permeability. Thus, constituents of cannabis, acting through the EC systems in the gut, brain and immune system, may be therapeutic. The existing literature suggests that the two principal constituents of cannabis, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), have differential effects on the ECS.
- Conditions
- HIV, Cannabis, THC, Neuroinflammatory Disease, Neuroinflammatory Response, Microbiome
- Being tested
- THC, CBD
- Medical subject headings
- Marijuana Abuse, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THCDrug
Also called Delta-9 tetrahydrocannabinol, Tetrahydrocannabinol, Delta9-THC
THC capsule
CBDDrug
Also called Cannabidiol
oral solution
| Study group | Role | What they receive |
|---|---|---|
| THC first, then CBD | Experimental | THC 10mg daily for 2 weeks, followed by washout for 2 weeks, followed by CBD 600mg daily for 2 weeks Receives: Drug: THC; Drug: CBD |
| CBD first, then THC | Active comparator | CBD 600mg daily for 2 weeks, followed by washout for 2 weeks, followed by THC 10mg daily for 2 weeks Receives: Drug: THC; Drug: CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
PC1
A composite marker of inflammation, comprising the first component (PC1, a unitless measure) of the principal component analysis (PCA) of 7 soluble biomarkers in blood (soluble CD163 [sCD163], interferon gamma [IFN-gamma], interleukin 6 [IL-6], C-reactive protein [CRP], CC motif chemokine ligand 2 [CCL2], neopterin and soluble tumor necrosis factor - type II [sTNFRII]), all measured in picograms/milliliter
Measured: Change from baseline to Week 2
PC1
A composite marker of inflammation, comprising the first component (PC1, a unitless measure) of the principal component analysis (PCA) of 7 soluble biomarkers in blood (soluble CD163 [sCD163], interferon gamma [IFN-gamma], interleukin 6 [IL-6], C-reactive protein [CRP], CC motif chemokine ligand 2 [CCL2], neopterin and soluble tumor necrosis factor - type II [sTNFRII]), measured in picograms/milliliter
Measured: Change from Week 4 to Week 6
Secondary outcomes (2)
blood-brain barrier (BBB)
BBB markers: claudin, suPAR, CSF/serum albumin ratio, MMP-2, occludin, all measured in picograms/milliliter
Measured: Change from baseline to Week 2
blood-brain barrier (BBB)
BBB markers: claudin, suPAR, CSF/serum albumin ratio, MMP-2, occludin, measured in picograms/milliliter
Measured: Change from Week 4 to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Sep 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a double-blind, randomized, 2-sequence crossover trial of CBD versus THC to reduce systemic and neuro-inflammation. This design was chosen to balance consideration of addressing the key scientific questions (effects of CBD versus THC on the microbiome, ECS and inflammation and their interaction with HIV infection), scientific rigor, power and feasibility.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Ellis, University of California, San Diego
- Investigators
- Ronald J Ellis, MD, PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514899
- Sponsor's protocol ID
- 802514
- Acronym
- CAMI
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be considered upon request
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV
- ClinicalTrials.gov ID
- NCT05514899
- Acronym / sponsor ID
- CAMI / 802514
- Conditions
- HIV, Cannabis, THC, Neuroinflammatory Disease, Neuroinflammatory Response, Microbiome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project will characterize the microbiome and endocannabinoid system (ECS) in people with HIV (PWH) and how they relate to neuroinflammation and blood-brain barrier (BBB) function. The study hypothesizes that pathogenic alterations in the gut microbiota (dysbiosis) and impaired gut barrier integrity (leaky gut) are mediators between the ECS, neuroinflammation and BBB dysfunction in HIV. The major goals are to (1) characterize the gut microbiota and ECS in response to exogenous cannabinoid exposure in both PWH and people without HIV (PWoH); (2) characterize patterns of HIV-associated inflammation (innate, adaptive, T-cell, B-cell) in blood and cerebrospinal fluid (CSF) in response to controlled cannabis exposure; (3) assess effects of cannabinoid exposure on these patterns and how they are mediated through changes in the ECS, gut microbiota and gut barrier function. The investigators will perform a clinical trial of 50 PWH and 50 PWoH exposed in a randomized, cross-over fashion to 14 days each of oral THC and CBD to determine if treatment with either phytocannabinoid reduces inflammation and improves gut function. The experimental approach will use fecal shotgun metagenomic sequencing to characterize the gut microbiome, with particular attention to aerotolerant bacteria, pro-inflammatory species, Prevotella spp., Bifidobacterium and Bacteroides spp. and butyrate-producing bacteria. We will evaluate how the microbiota and leaky gut relate to neuroinflammation and impaired BBB function, the latter potentially leading to increased central nervous system (CNS) exposure to microbially-produced pro-inflammatory ligands. The rationale for the study is that virologic suppression on antiretroviral therapy (ART) does not normalize gut lymphoid tissue cluster of differentiation 4 (CD4)+ T cell depletion, leaky gut, dysbiosis, chronic gut inflammation, and microbial antigen translocation (MAT). These alterations ultimately drive systemic and CNS inflammation. Compromised gut barrier function due to altered tight junctions, apoptosis and reduced epithelial cell proliferation and repair render PWH susceptible to increased tissue exposure to pro-inflammatory ligands produced by gut microbiota and are important in HIV neuropathogenesis. Of particular relevance here are recent findings that the ECS in the large intestine interacts with the gut microbiota to regulate epithelial barrier permeability. Thus, constituents of cannabis, acting through the EC systems in the gut, brain and immune system, may be therapeutic. The existing literature suggests that the two principal constituents of cannabis, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), have differential effects on the ECS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a double-blind, randomized, 2-sequence crossover trial of CBD versus THC to reduce systemic and neuro-inflammation. This design was chosen to balance consideration of addressing the key scientific questions (effects of CBD versus THC on the microbiome, ECS and inflammation and their interaction with HIV infection), scientific rigor, power and feasibility.
| Arm | Type | Receives |
|---|---|---|
| THC first, then CBD | Experimental | Drug: THC, Drug: CBDTHC 10mg daily for 2 weeks, followed by washout for 2 weeks, followed by CBD 600mg daily for 2 weeks |
| CBD first, then THC | Active comparator | Drug: THC, Drug: CBDCBD 600mg daily for 2 weeks, followed by washout for 2 weeks, followed by THC 10mg daily for 2 weeks |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- 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
- 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
- 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;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THCAlso: Delta-9 tetrahydrocannabinol, Tetrahydrocannabinol, Delta9-THCTHC capsule | Drug | CBD first, then THC, THC first, then CBD |
| CBDAlso: Cannabidioloral solution | Drug | CBD first, then THC, THC first, then CBD |
Primary outcome
PC1
Time frame: Change from baseline to Week 2
A composite marker of inflammation, comprising the first component (PC1, a unitless measure) of the principal component analysis (PCA) of 7 soluble biomarkers in blood (soluble CD163 [sCD163], interferon gamma [IFN-gamma], interleukin 6 [IL-6], C-reactive protein [CRP], CC motif chemokine ligand 2 [CCL2], neopterin and soluble tumor necrosis factor - type II [sTNFRII]), all measured in picograms/milliliter
PC1
Time frame: Change from Week 4 to Week 6
A composite marker of inflammation, comprising the first component (PC1, a unitless measure) of the principal component analysis (PCA) of 7 soluble biomarkers in blood (soluble CD163 [sCD163], interferon gamma [IFN-gamma], interleukin 6 [IL-6], C-reactive protein [CRP], CC motif chemokine ligand 2 [CCL2], neopterin and soluble tumor necrosis factor - type II [sTNFRII]), measured in picograms/milliliter
2 secondary outcomes
blood-brain barrier (BBB)
Time frame: Change from baseline to Week 2
blood-brain barrier (BBB)
Time frame: Change from Week 4 to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. Data sharing will be considered upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald J Ellis, MD, PhD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THC and CBD in people with HIV and Cannabis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Gallardo (619-543-5000, hnrprecruitment@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PC1 (time frame: Change from baseline to Week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.