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Chronic Cannabis Use for HIV/AIDS Neuroinflammation (CHI Trial)
Phase 3
Recruiting
Led By Christina S Meade, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable cART regimen (HIV+ participants only)
Receipt of cART as first-line of treatment (HIV+ participants only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-year follow-up, and 2-year follow-up
Awards & highlights
CHI Trial Summary
This trial looks at how chronic marijuana use affects HIV-associated inflammation and central nervous system function.
Who is the study for?
This trial is for adults with HIV who are on a stable cART regimen, have used marijuana chronically (for the MJ+ group), or have not used it at all (for the MJ- group). They must be engaged in HIV care and have an undetectable viral load for over a year. People with serious neurological issues, MRI contraindications, drug abuse history (other than marijuana), low education or English fluency, severe head trauma, mental illness, or autoimmune diseases cannot join.Check my eligibility
What is being tested?
The study is testing how chronic marijuana use affects inflammation in the brain and nerve damage related to HIV. It involves neuropsychological tests to assess cognitive function; immune profiling to look at body defenses; and advanced MRI scans to visualize changes in brain structure and function.See study design
What are the potential side effects?
While this trial does not involve new drugs that could cause side effects directly, participants may experience discomfort from neuropsychological testing or side effects from their routine cART treatment. The MRI procedure might also be uncomfortable for some.
CHI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HIV positive and on a stable HIV medication regimen.
Select...
I am HIV positive and received cART as my first treatment.
CHI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-year follow-up, and 2-year follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-year follow-up, and 2-year follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in axonal damage was measured by neurofilament light (NfL) protein
Change in axonal loss and injury as measured by axonal diffusivity (AD)
Change in demyelination or dysmyelination as measured by radial diffusivity (RD)
+8 moreCHI Trial Design
4Treatment groups
Experimental Treatment
Group I: HIV- non-drug userExperimental Treatment3 Interventions
Participants without HIV who report no drug use
Group II: HIV- marijuana userExperimental Treatment3 Interventions
Participants without HIV who report marijuana use
Group III: HIV+ non-drug userExperimental Treatment3 Interventions
Participants with HIV who report no drug use
Group IV: HIV+ marijuana userExperimental Treatment3 Interventions
Participants with HIV who report marijuana use
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neuropsychological testing
2017
N/A
~570
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,510 Total Patients Enrolled
20 Trials studying Cannabis
1,316 Patients Enrolled for Cannabis
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,506 Total Patients Enrolled
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,266 Total Patients Enrolled
2 Trials studying Cannabis
113 Patients Enrolled for Cannabis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving treatment for HIV.You are not using marijuana at the moment (applies to the MJ group only).I have a systemic autoimmune disease.Your HIV status has been confirmed.If you have HIV, your viral load has been undetectable for more than one year.I do not have serious or unstable nerve-related conditions.I am HIV positive and on a stable HIV medication regimen.You have a serious mental illness.You have had a serious head injury in the past.I am currently receiving or have received immunotherapy.You are currently using marijuana.I am HIV positive and received cART as my first treatment.You have a history of using illegal drugs, except for marijuana.
Research Study Groups:
This trial has the following groups:- Group 1: HIV- non-drug user
- Group 2: HIV+ marijuana user
- Group 3: HIV- marijuana user
- Group 4: HIV+ non-drug user
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would this program consider people outside of the 35-year age limit?
"As this trial's guidelines state, individuals must be aged between 25-59 to be eligible for participation."
Answered by AI
Are there any specific requirements to enroll in this research project?
"The team is looking for 220 individuals aged between 25-59 that suffer from inflammation and also meet the following conditions: no recent marijuana use (for MJ groups only)."
Answered by AI
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