138 Participants Needed

Cannabis Derivatives for HIV

AM
CV
Overseen ByCrossby Vargas
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of California, San Diego
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationally, may indicate disease severity, impart therapeutic benefits, or adverse consequences. In fact, cannabis is recommended to those with HIV to alleviate nausea, improve appetite, relieve pain, and lift mood. To-date, the consequences of cannabis use in PWH remain unclear as do potential interactions with HIV treatments. In healthy participants, heavy cannabis use is associated with cognitive deficits e.g., risky decision-making, response disinhibition and inattention, but pro-cognitive effects in PWH may exist at mild use levels due to its anti-inflammatory and anti-excitotoxic properties. Furthermore, little has been done to determine the effects of cannabis use on the endocannabinoid (EC) system in general or in PWH. This study will determine the effects of the two primary cannabis constituents (Δ9-tetrahydrocannabinol \[THC\], cannabidiol \[CBD\]) vs. placebo on risky decision-making, response inhibition, reward learning, temporal perception, and motivation, plus EC and homovanillic acid (HVA; a surrogate for dopamine activity) levels in HIV+ and HIV- subjects. Participants with infrequent cannabis use will undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified. They will be randomized to a 5-day course of either THC, CBD, or placebo and return for follow-up testing and re-assaying of ECs and HVA levels.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does require participants to abstain from cannabis for at least 2 days before the baseline visit.

Is CBD safe for human use?

CBD is generally well tolerated in humans, but it can cause some side effects like diarrhea, sleepiness, and changes in liver function. It may also interact with other medications, so it's important to monitor for any adverse effects, especially in people with complex medical conditions.12345

How is the drug Cannabidiol and Δ9-tetrahydrocannabinol unique for treating HIV?

This drug is unique because it combines Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) to potentially reduce inflammation in people with HIV, which is not typically addressed by standard antiretroviral therapy. CBD, in particular, has shown anti-inflammatory properties without the psychoactive effects of THC, making it a novel option for managing chronic inflammation associated with HIV.26789

What evidence supports the effectiveness of the drug for reducing inflammation in people with HIV?

Research shows that cannabinoids like CBD and THC can reduce inflammation in people with HIV, which is important because chronic inflammation can lead to other health problems. Studies have found that these compounds can decrease inflammatory markers and improve immune cell function, suggesting potential benefits as an additional treatment alongside standard HIV therapy.126710

Who Is on the Research Team?

AM

Arpi Minassian, Ph.D.

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HIV who can consent to tests and have used cannabis infrequently (1-4 times per month) without adverse reactions. They must be willing to avoid cannabis for at least 2 days before the study starts, confirmed by an oral fluid test.

Inclusion Criteria

Willing to abstain from cannabis for at least 2 days prior the baseline visit. Although there is no definitive method for determining abstinence over this period, abstinence will be confirmed as best as possible by using an oral fluid testing device (Draeger 5000) employed by law enforcement officers to detect recent cannabis use. An oral fluid value of > 5ng suggests recent use, although in some cases it has been reported that individuals may show > 5ng up to 20 hours after use. Thus, should the oral fluid sample indicate > 5ng THC, the assessment may be canceled and rescheduled.
I can understand and agree to the study's procedures.
HIV Status: HIV status will be determined using the MedMira Rapid Test (Halifax, Nova Scotia, Canada). If the result differs from the participant's self-report a confirmatory Western Blot will be performed.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified

1 week
1 visit (in-person)

Treatment

Participants are randomized to a 5-day course of either THC, CBD, or placebo

5 days
5 visits (in-person)

Follow-up

Participants return for follow-up testing and re-assaying of ECs and HVA levels

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cannabidiol
  • Placebo
  • Δ9-tetrahydrocannabinol
Trial Overview The study examines how THC (10 mg), CBD (600 mg), or a placebo affect decision-making, cognition, motivation, and dopamine activity in people with HIV compared to those without. Participants will take their assigned treatment for five days.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: HIV-positive subjectsExperimental Treatment3 Interventions
Adult human subjects seropositive for HIV-1
Group II: Healthy Comparison VolunteersActive Control3 Interventions
Adult human subjects without HIV

Cannabidiol 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

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

Citations

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]
Cannabinoids and inflammation: implications for people living with HIV. [2020]
Knowledge of Cannabinoid Content Among People Living with HIV Who Use Cannabis: a Daily Diary Study. [2023]
Anti-inflammatory effects of CBD in human microglial cell line infected with HIV-1. [2023]
Immunomodulatory Potential of Cannabidiol in Multiple Sclerosis: a Systematic Review. [2023]
Cannabidiol Safety Data: A Systematic Mapping Study. [2023]
Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. [2021]
Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]
Cannabidiol: State of the art and new challenges for therapeutic applications. [2018]
Characterization of the butyl homologues of delta1-tetrahydrocannabinol, cannabinol and cannabidiol in samples of cannabis by combined gas chromatography and mass spectrometry. [2019]
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