Cannabis for HIV/AIDS Treatment Effects

Overseen By Roberto Gallardo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must be taking: Integrase inhibitors

Disqualifiers: Traumatic brain injury, Dementia, Stroke, Seizure disorder, Severe psychiatric disorder, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 to 11 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover how cannabis affects HIV treatment, mood, and cognitive function. Researchers will first observe regular cannabis users to understand its interaction with HIV medication. Then, they will administer cannabis (including CBD and THC forms) or a placebo to others to study its immediate effects. Individuals living with HIV who have maintained a stable drug regimen and are willing to temporarily abstain from cannabis may be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable antiretroviral therapy (ART) regimen for at least one month. You will also need to avoid grapefruit juice and cannabis for certain periods before assessments.

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

Past studies have shown that cannabis can reduce inflammation in people with HIV. Research suggests that daily cannabis use might help lower HIV viral levels, which is encouraging. However, safety remains a crucial consideration. Some studies indicate that THC cannabis may affect memory and behavior differently based on sex and other factors.

CBD cannabis has been studied in the form of Epidiolex, an FDA-approved prescription medicine for certain conditions. This approval indicates some level of safety, but reports of side effects like sleepiness and decreased appetite exist. In one study, serious side effects occurred in about 23% of participants, though this was with high doses. Any cannabis product can pose risks, and side effects might occur.

Overall, both THC and CBD cannabis have demonstrated some safety in research, but side effects are possible. Weighing the benefits against these potential risks is important when considering participation in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard HIV/AIDS treatments that use antiretroviral drugs to suppress the virus, the investigational cannabis treatments in this trial offer a novel approach by focusing on symptom relief and quality of life improvements. Researchers are particularly excited about THC Cannabis, which contains 11.86% THC, for its potential to alleviate pain and stimulate appetite in patients. Meanwhile, CBD Cannabis, with its high 11.27% CBD content, is being explored for its anti-inflammatory and anti-anxiety properties. These cannabis-based treatments could provide complementary benefits to traditional therapies, addressing symptoms that current medications might not effectively target.

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

This trial will compare the effects of THC Cannabis, CBD Cannabis, and a placebo in people with HIV/AIDS. Studies have shown that THC, a component of cannabis, might reduce inflammation and calm the immune system in people with HIV on antiretroviral therapy (ART), potentially improving overall health. Some evidence also suggests that THC may increase appetite and prevent weight loss in those with HIV/AIDS.

Research has indicated that CBD, another part of cannabis, may have anti-inflammatory effects and could be helpful in untreated HIV cases based on lab studies. However, other studies found that CBD alone had limited effects on the quality of life for people with HIV who have a long-term undetectable viral load. THC and CBD might affect mood and thinking differently, but more research is needed to fully understand their impact. ^{6 7 8 9 10}

Who Is on the Research Team?

Scott Letendre, MD

Principal Investigator

UCSD

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HIV/AIDS who are on a stable ART regimen and have used cannabis in the past two years without severe reactions. Participants must be willing to avoid cannabis, grapefruit juice, driving or operating heavy machinery as required by the study phases.

Inclusion Criteria

Presence of HIV infection by a standard diagnostic test;

Willing to abstain from grapefruit juice consumption for 4 weeks prior to the Phase 1 assessment.

Willing to abstain from cannabis for at least 48 hours prior to the cannabis administration visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Study

120 participants are assessed to evaluate the effects of chronic cannabis use on ART drug concentrations, mood, and thinking

Cross-sectional

1 visit (in-person)

Treatment

40 participants receive cannabis (or placebo) to examine its acute effects on ART drug concentrations

3 to 11 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBD Cannabis
• Placebo
• THC Cannabis

Trial Overview The study examines how cannabis affects antiretroviral therapy (ART) drug levels, mood, and cognitive function. It has two parts: an observational phase assessing chronic users of cannabis and a controlled phase where THC/CBD Cannabis or placebo is given to evaluate acute effects on ART.

How Is the Trial Designed?

Group I: THC Cannabis Active Control 1 Intervention

11.86% THC/ 1.12% CBD

Group II: CBD Cannabis Active Control 1 Intervention

0.35% THC/ 11.27% CBD

Group III: Placebo Placebo Group 1 Intervention

≤ 0.03% THC/ ≤ 0.05% CBD

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Center for Medicinal Cannabis Research

Collaborator

Trials

19

Recruited

630+

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]

Current preclinical data do not provide strong evidence that delta(9)-tetrahydrocannabinol (Δ(9)-THC) can cure cancer when administered systemically, suggesting that more research is needed to establish its efficacy in this context.

There is some support for using higher doses of Δ(9)-THC directly into tumors, and while cannabidiol (CBD) shows potential effects in relevant models, further studies are necessary to explore its effectiveness alongside other cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delta(9) -tetrahydrocannabinol and cannabidiol as potential curative agents for cancer: A critical examination of the preclinical literature. Fowler, CJ.[2015]

In a study involving 18 participants, vaporized CBD-dominant cannabis produced the highest blood concentration of CBD (171.1 ng/mL), significantly more than both vaporized CBD (104.6 ng/mL) and oral CBD formulations (13.7 ng/mL).

The study found that CBD alone does not convert to ∆9-THC, as ∆9-THC was only detected in participants using vaporized CBD-dominant cannabis, indicating that CBD-only products are unlikely to result in positive drug tests for THC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Profile of ∆9-Tetrahydrocannabinol, Cannabidiol and Metabolites in Blood following Vaporization and Oral Ingestion of Cannabidiol Products. Bergeria, CL., Spindle, TR., Cone, EJ., 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]

A systematic review of 34 studies found that high doses of cannabidiol (CBD) may be effective in treating conditions like social anxiety disorder, insomnia, and epilepsy, particularly at doses between 150-600 mg/day.

The review also highlighted that CBD can interact with ∆9-THC in complex ways, sometimes enhancing and other times inhibiting its effects, indicating the need for careful dosing and consideration of CBD's role in combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol in humans-the quest for therapeutic targets. Zhornitsky, S., Potvin, S.[2022]

A pilot randomized trial will assess the safety and tolerability of oral cannabis oils containing THC and CBD in 26 people living with HIV, focusing on their effects over 12 weeks.

The study aims to evaluate not only the safety of these cannabis oils but also their potential impact on inflammation, HIV persistence, and the gastrointestinal microbiome, which could inform future larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral cannabinoids in people living with HIV on effective antiretroviral therapy: CTN PT028-study protocol for a pilot randomised trial to assess safety, tolerability and effect on immune activation. Costiniuk, CT., Saneei, Z., Routy, JP., et al.[2020]

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]

Epidiolex, the only FDA-approved CBD-based drug, has been studied for its medicinal benefits and potential side effects across various clinical trials, focusing on both physiological and neurological conditions.

The review highlights that the outcomes of these trials can vary significantly based on the funding source, which may influence the reported efficacy and safety of Epidiolex and other CBD formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. Pauli, CS., Conroy, M., Vanden Heuvel, BD., et al.[2020]

In a study involving 18 healthy adults, vaporized CBD and CBD-dominant cannabis produced noticeable subjective effects, such as increased enjoyment, while oral CBD did not show any significant effects compared to placebo.

Importantly, neither vaporized CBD nor CBD-dominant cannabis caused cognitive or psychomotor impairment, suggesting that these forms of CBD may be safer alternatives to THC-dominant products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacodynamic effects of vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis in infrequent cannabis users. Spindle, TR., Cone, EJ., Goffi, E., et al.[2022]

Cannabidiol (CBD) is a non-psychoactive compound from cannabis that can counteract the psychotropic effects of THC and has gained popularity in various therapeutic products, especially after the FDA approved Epidiolex® for treating severe epilepsy in children.

Despite its therapeutic potential, there is a lack of consistent international regulations governing the marketing and authorization of CBD products, which raises concerns about product safety and efficacy for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology and legal status of cannabidiol. Brunetti, P., Lo Faro, AF., Pirani, F., et al.[2021]

Citations

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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 ( ...

2. 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 ...

3. biorxiv.org biorxiv.org/content/10.1101/2025.09.25.678534v1.full-text

Antiviral and Anti-inflammatory Effects of Cannabidiol in ... These findings show beneficial effects of CBD in laboratory models of untreated HIV, thus placebo-controlled clinical trials to evaluate the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05514899

Study Details | NCT05514899 | Effects of Cannabidiol and ... 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0889159125001679

Beneficial and adverse effects of THC on cognition in the ... A recent review of clinical and preclinical literature indicated that cannabis use among PLWH is rarely linked to worsened cognitive outcomes and, in fact, may ...

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

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Many concerns have been raised about CBD use, particularly with regard to over-the-counter. CBD products, as there are limited data on their safety and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7052834/

Cannabidiol Adverse Effects and Toxicity - PMC Severe AEs occurred in 20 (23%) of 86 patients in the CBD group including sleep apnea. Twelve (14%) patients treated with CBD and one (1%) treated with placebo ...

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

EPIDIOLEX (cannabidiol) oral solution - accessdata.fda.gov The most common adverse reactions that occurred in EPIDIOLEX-treated patients (incidence at least 10% and greater than placebo) were somnolence; decreased ...

9. epidiolexhcp.com epidiolexhcp.com/resources/frequently-asked-questions

Frequently Asked Questions | EPIDIOLEX® (cannabidiol) EPIDIOLEX is the first and only FDA-approved prescription cannabidiol and the only cannabidiol formulation demonstrated in well-controlled clinical trials to ...

10. cdc.gov cdc.gov/cannabis/about/about-cbd.html

About CBD | Cannabis and Public Health Using CBD products is not risk free. The FDA has limited data on CBD safety. Please consider these possible side effects and risks before using ...