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

Trial Summary

What is the purpose of 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.

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.

How does the drug CBD + THC for HIV/AIDS differ from other treatments?

The CBD + THC drug for HIV/AIDS is unique because it targets chronic inflammation, a common issue in people with HIV, by using cannabinoids that may reduce inflammatory markers and immune cell activation, potentially offering benefits beyond standard antiretroviral therapy. ^{1 2 3 4 5}

Research Team

Ronald J Ellis, MD, PhD

Principal Investigator

UC San Diego

Eligibility Criteria

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.

I am between 21 and 70 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Knowledge of Cannabinoid Content Among People Living with HIV Who Use Cannabis: a Daily Diary Study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cannabinoids and inflammation: implications for people living with HIV. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Anti-inflammatory effects of CBD in human microglial cell line infected with HIV-1. [2023]

5. United States 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. [2021]