HIV InfectionsCHAMPSNCT05430490
Cannabis, HIV and Mental Processing Systems
An observational study of HIV Infections and Cannabis, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
This study employs novel methods to identify key determinants and consequences of concurrent HIV infection and regular cannabis use. This study will acquire extensive phenotype data from peripheral and brain markers of immune activation, brain structure, and neuropsychological performance (NP) in persons living with… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Cannabis
- What is being tested?
- MRI, NeuroPsychological Testing and Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 276 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Mar 2022to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 160 PLWH (80 regular cannabis users and 80 non-users) and 160 demographically similar healthy HIV- controls (80 regular cannabis users and 80 non-users) may undergo multimodal neuroimaging, immunophenotyping (including blood and cerebrospinal fluid), and neuropsychological testing to address the specific aims.
Who may be able to join
- Participants must be 18-70 years old.
- PLWH must have documented HIV infection for approximately 1 year, be on a cART regimen for approximately ≥3 months, and be virally well-controlled (< 200 copies/mL).
- HIV- controls must have confirmed HIV- serostatus.
- Participants must complete at least 9 years of education.
- Participants must be able to provide informed consent.
- Female participants must have a negative pregnancy test or written documentation of tubal ligation, hysterectomy, post-menopausal status, etc. and cannot be breastfeeding.
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- Participants should have no contraindications to an MRI scan.
- Participants should be willing to have cannabis use history confirmed via clinical interview and urine analysis .
- All inclusion criteria at PI discretion.
Who cannot join
- History of neurological disorder (e.g., stroke, head injury with loss of consciousness for >5 minutes, developmental learning disability, etc.).
- Uncontrolled major affective disorder; history of bipolar disorder or schizophrenia. Major depression controlled with no hospitalizations or suicidal ideation in the past year is allowed.
- Current substance use disorder (SUD) as defined by DSM-5 criteria besides cannabis use disorder (CUD) (though a past SUD > 1 year before the time of study enrolment will be allowed).
- currently prescribed anti-coagulants (only exclusionary if participant will engage in optional LP).
- an allergy to lidocaine or similar anesthetic (only exclusionary if participant will engage in optional LP).
- a history of a bleeding disorder (only exclusionary if participant will engage in optional LP).
- claustrophobia or a pacemaker that would prevent magnetic resonance imaging (MRI) scanning.
- all exclusion criteria at PI discretion.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers University
Newark, New Jersey, 08901
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This study employs novel methods to identify key determinants and consequences of concurrent HIV infection and regular cannabis use. This study will acquire extensive phenotype data from peripheral and brain markers of immune activation, brain structure, and neuropsychological performance (NP) in persons living with HIV (PLWH) receiving combination anti-retroviral therapy (cART) (80 regular cannabis users and 80 non-users) and HIV uninfected (HIV-) controls (80 regular cannabis users and 80 non-users). This study will provide key insights into the effects of regular cannabis and HIV on peripheral and brain markers of immune function and NP in PLWH and HIV- controls. These insights are critical for cure strategies and ongoing HIV treatment initiatives.
- Conditions
- HIV Infections, Cannabis
- Being tested
- MRI, NeuroPsychological Testing, Blood Draw, Questionnaires, Lumbar Puncture
- Medical subject headings
- HIV Infections, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Multimodal neuroimaging on 3T Prisma Fit MRI
NeuroPsychological TestingOther
A series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions.
Blood DrawProcedure or surgery
Laboratory reports (CMP, CBC, Lipids)
QuestionnairesOther
Life history, current behaviors, and substance use surveys
Lumbar PunctureProcedure or surgery
Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back
| Study group | Role | What they receive |
|---|---|---|
| HIV+ Cannabis User | Persons diagnosed with HIV who identify as using medical or recreational marijuana Receives: Procedure: MRI; Other: NeuroPsychological Testing; Procedure: Blood Draw; Other: Questionnaires; Procedure: Lumbar Puncture | |
| HIV+ Cannabis Non-User | Persons diagnosed with HIV who identify as not using medical or recreational marijuana Receives: Procedure: MRI; Other: NeuroPsychological Testing; Procedure: Blood Draw; Other: Questionnaires; Procedure: Lumbar Puncture | |
| HIV- Cannabis User | Persons without HIV who identify as using medical or recreational marijuana Receives: Procedure: MRI; Other: NeuroPsychological Testing; Procedure: Blood Draw; Other: Questionnaires; Procedure: Lumbar Puncture | |
| HIV- Cannabis Non-User | Persons without HIV who identify as not using medical or recreational marijuana Receives: Procedure: MRI; Other: NeuroPsychological Testing; Procedure: Blood Draw; Other: Questionnaires; Procedure: Lumbar Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of cannabis use on peripheral and brain immune activation and inflammation in virally controlled PLWH on cART.
Validated plasma and cerebrospinal fluid (CSF) markers of immune health and inflammation (e.g., CD14, CD16, Neopterin, etc.), as well as novel neuroimaging methods of neuro-inflammation (e.g., DTI \& DBSI, 3T MRI) will be used to evaluate brain inflammation.
Measured: Years 1-5
Secondary outcomes (1)
Effect of cannabis use on cognitive performance and brain structure in both PLWH/CB+ and CON/CB+.
Neuropsychological assessment results will be normed and converted into Z scores for comparison with brain volumes calculated from the 3T.
Measured: Years 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start23 Mar 2022
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430490
- Sponsor's protocol ID
- 202107149
- Acronym
- CHAMPS
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2022
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis, HIV and Mental Processing Systems
- ClinicalTrials.gov ID
- NCT05430490
- Acronym / sponsor ID
- CHAMPS / 202107149
- Conditions
- HIV Infections, Cannabis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Rutgers University
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study employs novel methods to identify key determinants and consequences of concurrent HIV infection and regular cannabis use. This study will acquire extensive phenotype data from peripheral and brain markers of immune activation, brain structure, and neuropsychological performance (NP) in persons living with HIV (PLWH) receiving combination anti-retroviral therapy (cART) (80 regular cannabis users and 80 non-users) and HIV uninfected (HIV-) controls (80 regular cannabis users and 80 non-users). This study will provide key insights into the effects of regular cannabis and HIV on peripheral and brain markers of immune function and NP in PLWH and HIV- controls. These insights are critical for cure strategies and ongoing HIV treatment initiatives.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV+ Cannabis User | – | Procedure: MRI, Other: NeuroPsychological Testing, Procedure: Blood Draw, Other: Questionnaires, Procedure: Lumbar PuncturePersons diagnosed with HIV who identify as using medical or recreational marijuana |
| HIV+ Cannabis Non-User | – | Procedure: MRI, Other: NeuroPsychological Testing, Procedure: Blood Draw, Other: Questionnaires, Procedure: Lumbar PuncturePersons diagnosed with HIV who identify as not using medical or recreational marijuana |
| HIV- Cannabis User | – | Procedure: MRI, Other: NeuroPsychological Testing, Procedure: Blood Draw, Other: Questionnaires, Procedure: Lumbar PuncturePersons without HIV who identify as using medical or recreational marijuana |
| HIV- Cannabis Non-User | – | Procedure: MRI, Other: NeuroPsychological Testing, Procedure: Blood Draw, Other: Questionnaires, Procedure: Lumbar PuncturePersons without HIV who identify as not using medical or recreational marijuana |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 160 PLWH (80 regular cannabis users and 80 non-users) and 160 demographically similar healthy HIV- controls (80 regular cannabis users and 80 non-users) may undergo multimodal neuroimaging, immunophenotyping (including blood and cerebrospinal fluid), and neuropsychological testing to address the specific aims.
Key inclusion criteria (9 listed)
- Participants must be 18-70 years old.
- PLWH must have documented HIV infection for approximately 1 year, be on a cART regimen for approximately ≥3 months, and be virally well-controlled (< 200 copies/mL).
- HIV- controls must have confirmed HIV- serostatus.
- Participants must complete at least 9 years of education.
- Participants must be able to provide informed consent.
Key exclusion criteria (8 listed)
- History of neurological disorder (e.g., stroke, head injury with loss of consciousness for >5 minutes, developmental learning disability, etc.).
- Uncontrolled major affective disorder; history of bipolar disorder or schizophrenia. Major depression controlled with no hospitalizations or suicidal ideation in the past year is allowed.
- Current substance use disorder (SUD) as defined by DSM-5 criteria besides cannabis use disorder (CUD) (though a past SUD > 1 year before the time of study enrolment will be allowed).
- currently prescribed anti-coagulants (only exclusionary if participant will engage in optional LP).
- an allergy to lidocaine or similar anesthetic (only exclusionary if participant will engage in optional LP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMultimodal neuroimaging on 3T Prisma Fit MRI | Procedure or surgery | HIV+ Cannabis Non-User, HIV+ Cannabis User, HIV- Cannabis Non-User, HIV- Cannabis User |
| NeuroPsychological TestingA series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions. | Other | HIV+ Cannabis Non-User, HIV+ Cannabis User, HIV- Cannabis Non-User, HIV- Cannabis User |
| Blood DrawLaboratory reports (CMP, CBC, Lipids) | Procedure or surgery | HIV+ Cannabis Non-User, HIV+ Cannabis User, HIV- Cannabis Non-User, HIV- Cannabis User |
| QuestionnairesLife history, current behaviors, and substance use surveys | Other | HIV+ Cannabis Non-User, HIV+ Cannabis User, HIV- Cannabis Non-User, HIV- Cannabis User |
| Lumbar PunctureOptional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back | Procedure or surgery | HIV+ Cannabis Non-User, HIV+ Cannabis User, HIV- Cannabis Non-User, HIV- Cannabis User |
Primary outcome
Effect of cannabis use on peripheral and brain immune activation and inflammation in virally controlled PLWH on cART.
Time frame: Years 1-5
Validated plasma and cerebrospinal fluid (CSF) markers of immune health and inflammation (e.g., CD14, CD16, Neopterin, etc.), as well as novel neuroimaging methods of neuro-inflammation (e.g., DTI \& DBSI, 3T MRI) will be used to evaluate brain inflammation.
1 secondary outcome
Effect of cannabis use on cognitive performance and brain structure in both PLWH/CB+ and CON/CB+.
Time frame: Years 1-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Cannabis, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of cannabis use on peripheral and brain immune activation and inflammation in virally controlled PLWH on cART. (time frame: Years 1-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.