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Cannabinoid

CBD + THC for HIV/AIDS (CAMI Trial)

Phase 2
Recruiting
Led By Ronald J Ellis, MD, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to week 2
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of cannabis use and HIV on the brain and inflammation. Participants will be given the same treatment in a different order over 6 weeks to monitor safety and measure the effects of the drug.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of CBD/THC may include altered mental state or mood changes; digestive issues such as nausea; fatigue; changes in appetite; dry mouth; potential elevation of liver enzymes which could indicate liver irritation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PC1
Secondary study objectives
blood-brain barrier (BBB)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: THC first, then CBDExperimental Treatment2 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 THCActive Control2 Interventions
CBD 600mg daily for 2 weeks, followed by washout for 2 weeks, followed by THC 10mg daily for 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THC
2017
Completed Phase 1
~440
CBD
2016
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,957 Total Patients Enrolled
Ronald J Ellis, MD, PhDPrincipal InvestigatorUC San Diego
2 Previous Clinical Trials
132 Total Patients Enrolled

Media Library

CBD (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05514899 — Phase 2
HIV/AIDS Clinical Trial 2023: CBD Highlights & Side Effects. Trial Name: NCT05514899 — Phase 2
~56 spots leftby Jul 2027
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