CBD + THC for HIV/AIDS

(CAMI Trial)

Overseen By Roberto Gallardo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must be taking: ART

Must not be taking: Sedating medications

Disqualifiers: Substance use disorder, Dementia, Pregnancy, Cardiovascular risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how CBD and THC, two cannabis compounds, affect the brain and inflammation in people with HIV. Researchers aim to understand the separate and combined impacts of these substances, which might aid in developing better treatments for brain and inflammation issues. Participants will be divided into two groups to receive either THC first or CBD first, each for two weeks, with a break in between. Ideal candidates for this trial are people with HIV who are on stable treatment and have used cannabis without major issues. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications with significant interactions or sedating effects. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CBD (cannabidiol) and THC (tetrahydrocannabinol) are generally safe, though they can cause some side effects.

For THC, studies on a version called dronabinol, used by people with HIV/AIDS, showed it is mostly well-tolerated. Common side effects include dizziness, dry mouth, and sleepiness. Some individuals might also experience mood changes or feel high.

CBD is considered safe for most people, but it can cause tiredness, diarrhea, and changes in appetite or weight. These side effects are usually mild.

Both CBD and THC have FDA approval for other uses, which supports their safety. However, individual reactions can vary. Always consult a healthcare provider if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using CBD and THC for HIV/AIDS management because these compounds offer a new approach to symptom relief and quality of life improvement. Unlike traditional antiretroviral therapies that primarily focus on controlling virus levels, CBD and THC target inflammation and pain, potentially easing discomfort and improving mood. The unique combination of these compounds may provide a more holistic treatment option, addressing both physical and mental health aspects of living with HIV/AIDS. Additionally, the natural origin of CBD and THC might appeal to patients seeking alternative or complementary therapies.

What evidence suggests that this trial's treatments could be effective for HIV/AIDS?

This trial will compare the effects of CBD and THC on inflammation in people with HIV. Research has shown that both CBD and THC might help reduce inflammation in this population. Participants in one arm of the trial will receive THC first, followed by CBD, while those in the other arm will receive CBD first, followed by THC. CBD may lower inflammation and immune system activity, common issues for those with HIV. Some studies suggest that CBD can also slow cell aging, potentially lessening the harmful effects of inflammation. THC has shown promising results, with studies indicating that oral intake can reduce overall inflammation. These findings suggest that CBD and THC could help manage inflammation related to HIV. ^{6 7 8 9 10}

Who Is on the Research Team?

Ronald J Ellis, MD, PhD

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

This trial is for adults aged 21-60 who have used THC-containing cannabis at least once in the past 5 years without severe side effects and have low or no cannabis use recently. HIV-positive participants must be virally suppressed, on stable ART with a 'normal' CD4 count, and able to follow the study schedule. Exclusions include significant cognitive impairment, compromised liver/kidney function, allergies to study drugs, heavy substance use (except cannabis), pregnancy/lactation without contraception, certain chronic diseases like diabetes requiring insulin or uncontrolled psychiatric disorders.

Inclusion Criteria

I can understand and agree to medical assessments.

I have not used cannabis or only used it once in the last 2 weeks.

Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention

Exclusion Criteria

I do not have severe depression, psychosis, or thoughts of suicide.

Significant cognitive impairment such as Dementia, including Alzheimer's disease

My liver or kidney function is moderately to severely impaired.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either THC or CBD for 2 weeks, followed by a 2-week washout period, and then the alternate treatment for another 2 weeks

6 weeks

Multiple visits for physical examinations, blood tests, and other procedures

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBD
• THC

Trial Overview The trial studies how Cannabidiol (CBD) and Tetrahydrocannabinol (THC) affect the brain's microbiome and inflammation in people with HIV. Participants will receive both treatments over about 6 weeks but in different orders. They'll undergo physical exams, blood tests, and other procedures to monitor safety and measure drug effects.

How Is the Trial Designed?

Group I: THC first, then CBD Experimental Treatment 2 Interventions

THC 10mg daily for 2 weeks, followed by washout for 2 weeks, followed by CBD 600mg daily for 2 weeks

Group II: CBD first, then THC Active Control 2 Interventions

CBD 600mg daily for 2 weeks, followed by washout for 2 weeks, followed by THC 10mg daily for 2 weeks

CBD is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Among people living with HIV who use cannabis, knowledge of THC and CBD concentrations is more common when using non-flower cannabis products compared to flower forms, indicating that product type may influence awareness.

Greater knowledge of cannabinoid concentrations is linked to fewer negative consequences from cannabis use, especially among those who primarily use cannabis for medicinal purposes, suggesting that education on cannabinoid content could enhance safety and efficacy in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge of Cannabinoid Content Among People Living with HIV Who Use Cannabis: a Daily Diary Study. Coelho, SG., Rueda, S., Costiniuk, CT., et al.[2023]

Cannabis, particularly Δ-Tetrahydrocannabinol (Δ-THC), shows promise in reducing chronic inflammation and improving immune responses in people living with HIV (PLWH), potentially lowering the risk of comorbidities like cardiovascular disease and diabetes.

In studies, cannabis use among ART-treated PLWH did not negatively impact CD4 T-cell counts or HIV control, and was associated with lower levels of T-cell activation and inflammatory markers, suggesting it may be beneficial as an adjunct therapy to standard HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoids and inflammation: implications for people living with HIV. Costiniuk, CT., Jenabian, MA.[2020]

Cannabidiol (CBD) effectively reduces the production of inflammatory cytokines and chemokines in human microglial cells infected with HIV, showing its potential as an anti-inflammatory treatment.

CBD not only deactivates key components of the inflammasome pathway but also significantly lowers HIV expression, indicating its therapeutic potential against both HIV-1 infections and associated neuroinflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-inflammatory effects of CBD in human microglial cell line infected with HIV-1. Yndart Arias, A., Kolishetti, N., Vashist, A., et al.[2023]

A single oral dose of 750 mg of cannabidiol (CBD) showed significantly increased exposure when taken with a high-fat/calorie meal, with a 3.8-fold increase in overall exposure (AUC0-∞) and a 5.2-fold increase in maximum concentration (Cmax) compared to fasting.

CBD was well-tolerated with no severe adverse events reported, indicating its safety in healthy adults, while its absorption was also enhanced by low-fat meals, whole milk, and alcohol, albeit to a lesser extent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects. Crockett, J., Critchley, D., Tayo, B., et al.[2021]

In a study involving 10 people with HIV on antiretroviral therapy, oral cannabinoids (THC and CBD) significantly reduced levels of inflammatory cytokines and certain immune cell subsets after 12 weeks, suggesting potential anti-inflammatory benefits.

Despite these reductions in inflammation, the study found no significant changes in HIV DNA/RNA levels, indicating that while cannabinoids may help with inflammation, they do not appear to affect the viral load in the participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Oral Cannabinoids on Systemic Inflammation and Viral Reservoir Markers in People with HIV on Antiretroviral Therapy: Results of the CTN PT028 Pilot Clinical Trial. Mboumba Bouassa, RS., Comeau, E., Alexandrova, Y., et al.[2023]

Citations

1. academic.oup.com academic.oup.com/ofid/article/11/9/ofae492/7742708

Limited Impact of Cannabidiol on Health-related Quality of Life ... To conclude, twice-daily full-spectrum CBD oil at 1 mg/kg had no major effect on HRQoL in PWH with long-term undetectable HIV viral load. Large-size randomized ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8402692/

Cannabis and Inflammation in HIV: A Review of Human and ... This brief review will cover potential benefits of cannabis in reducing persistent inflammation and immune activation in virally suppressed people with HIV (PWH) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05306249

Study Details | NCT05306249 | Effects of Cannabidiol ... Thus, CBD, which has no psychotropic effect, could have beneficial effects on HIV patients by reducing cellular senescence, inflammation and their consequences ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10378564/

Effects of Oral Cannabinoids on Systemic Inflammation and ... In the present study, REG-3 α plasma levels decreased after 12 weeks of oral cannabinoid treatment. These results are promising since increased gut mucosal ...

5. mmjoutcomes.org mmjoutcomes.org/media/mmj/factsheets/MMJ-for-HIV.pdf

medical marijuana for hiv/aids? what you should know. A Mapping Literature Review of Medical Cannabis Clinical Outcomes and Quality of Evidence in Approved Conditions in the USA from 2016 to 2019. Med Cannabis.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf

EPIDIOLEX (cannabidiol) oral solution - accessdata.fda.gov most common adversereactions (10% or more for EPIDIOLEX and greater than placebo) are: somnolence; decreased appetite; diarrhea; transaminase elevations; ...

7. epidiolexhcp.com epidiolexhcp.com/efficacy-and-safety/safety

Safety and Tolerability | EPIDIOLEX® (cannabidiol) EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569602/

An Update on Safety and Side Effects of Cannabidiol Here, the most commonly reported side effects were tiredness, diarrhea, and changes of appetite/weight. In comparison with other drugs, used for the treatment ...

9. library.samhsa.gov library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... CBD products, as there are limited data on their safety and effectiveness.4 ... by weight;36 it is unlikely that pure CBD will produce a positive urine drug test.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9775551/

Safety and Tolerability of Oral Cannabinoids in People Living ... Conclusions: In PLWH, cannabinoids seem generally safe and well-tolerated, though larger studies are needed.