Effects of cannabis on HIV treatment and brain health

Cannabis Effects on Antiretroviral Therapy Pharmacokinetics and Neurotoxicity

This study is testing how using cannabis affects the effectiveness and safety of HIV treatment in people living with the virus.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Diego (Academic / other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT04800159 on ClinicalTrials.gov

What this trial studies

This study investigates how cannabis use impacts the effectiveness and safety of antiretroviral therapy (ART) in individuals with HIV. It consists of two phases: the first phase is observational, assessing 120 participants to evaluate the effects of chronic cannabis use on ART drug concentrations, mood, and cognitive function. The second phase involves administering cannabis or a placebo to 40 participants to examine its acute effects on ART drug concentrations. The study aims to understand the potential benefits and risks of cannabis use in the context of HIV treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with HIV who are on a stable ART regimen and have used cannabis in the past two years.

Not a fit: Patients who do not have HIV or are not on ART may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimizing HIV treatment for patients who use cannabis.

How similar studies have performed: While there is limited research specifically on cannabis and ART, studies on cannabis effects in other medical contexts have shown varying results, indicating this area is still being explored.

Eligibility criteria

Inclusion Criteria for All Visits:

1. Age 18 or older;
2. Capacity to provide informed consent;
3. Presence of HIV infection by a standard diagnostic test;
4. On a stable ART regimen for at least 1 month and with a suppressed viral load by self-report;
5. Willing to abstain from cannabis for at least 24 hours prior to the Phase 1 assessment.
6. Willing to abstain from grapefruit juice consumption for 4 weeks prior to the Phase 1 assessment.

Additional Inclusion Criteria for participation in Phase 2 (interventional):

1. Treatment with an integrase inhibitor (i.e. dolutegravir);
2. Use of cannabis in the past two years without a severe adverse reaction (e.g., disorientation, paranoia, or hallucinations). The two-year cutoff is to ensure exposure to modern cannabis, which is more likely to match the drug concentrations administered in this study;
3. Willing to refrain from driving or operating heavy machinery after the visit; and
4. Willing to abstain from cannabis for at least 48 hours prior to the cannabis administration visits.
5. Willing to abstain from grapefruit juice consumption for 4 weeks prior to cannabis administration and during the administration visits

Exclusion Criteria for All Visits:

1. Traumatic brain injury, including head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications;
2. Dementia, including Alzheimer's disease;
3. History of stroke with residual neurologic sequelae;
4. History of seizure disorder with a seizure in the past year;
5. Severe psychiatric disorder (e.g., schizophrenia) that might make the person's participation in the study unsafe;
6. Substance or alcohol use disorder in the past 3 months;
7. Contraindications to lumbar puncture for those consenting to lumbar puncture (e.g., coagulopathy).

Additional Exclusion Criteria for participation in the cannabis administration visits:

1. Younger than 21 years (due to safety of cannabis in children and adolescents);
2. Respiratory condition that would be exacerbated by inhaling vaporized cannabis (e.g., asthma or chronic obstructive pulmonary disease) or limited lung capacity that would prevent the individual from performing the Foltin puff procedure;
3. History of cardiovascular disease, including myocardial infarction;
4. Uncontrolled hypertension with systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 100 mm Hg prior to study product administration;
5. Resting pulse greater than 100 beats per minute prior to study product administration;
6. Pregnancy as determined by a human chorionic gonadotropin urine test, women who are lactating, or unwillingness to prevent pregnancy during the cannabis administration portion of the study (using birth control in women of child-bearing age). Acceptable methods of birth control are: oral contraceptive pills, diaphragm, condom, progestin implant, intrauterine contraceptive device, sterilization, etc;
7. Active opportunistic infection or malignancy requiring treatment;
8. Unintentional loss of 10% or more of body weight during the previous 6 months;
9. CD4+ T-cell count less than 200 cells/µL;
10. Estimated glomerular filtration rate \< 30 mL/minute, indicative of renal dysfunction;
11. Hepatic transaminases \> 2 times the upper limit of normal;
12. Current severe depressive symptoms (BDI-II score ≥ 31) or suicidal ideation;
13. Known sensitivity to acetaminophen (the probe for UGT activity);
14. Current use of substances that could have adverse interactions with acetaminophen or cannabis (e.g., grapefruit juice).

Where this trial is running

San Diego, California

• Ucsd Hnrp-Cmcr — San Diego, California, United States (Recruiting)

Study contacts

• Principal investigator: Scott Letendre, MD — UCSD
• Study coordinator: Roberto Gallardo

Conditions HIV; Cannabis Use