Youth With HIVNCT03927053
Consequences of Marijuana Use in HIV-infected Youth
An observational study of Youth With HIV, run by Duke University at 2 sites in United States.
Trial summary
Proposed study focuses on Youth With HIV (YWH) recruited from the University of North Carolina using a cross sectional assessment of blood samples, clinical, demographic, behavioral, [including substance use and frequency], and neurocognitive data will be evaluated from YWH treated before CD4 T cell decline. Read more about this study
- Who is it for?
- Ages 21 to 28 years
- Conditions the study is for
- Youth With HIV
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2019to 15 Oct 2021
- 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 21 to 28 years
- All sexes
- No healthy volunteers
- Adult
Study population: Enrollment will consist of approximately 61 HIV-infected youth meeting the below entry criteria who are receiving antiretroviral therapy with undetectable viral levels at the time of entry (based on viral load assay within 1 year of enrollment) Recruitment will include Youth Age 21-28 * Youth who use marijuana only [targeted number 20 participants] * Youth who use tobacco products only [targeted number 24 participants] * Youth who use marijuana and tobacco [targeted number 7 participants] * Youth who do not use substances [targeted number 10 participants]
Who may be able to join
- Age 21 years 0 days - less than28 years 364 days
- Currently treated with stable ART and no ART changes for >6months.
- Willingness to participate in CASI questionnaire of self-reported substance use
- Documented behavioral transmission of HIV infection based on CLIA approved HIV antibody/antigen based testing method in medical record -HIV diagnosis greater than or equal to years. Viral load LESS THAN 50 COPIES/ML for the past 6 months. --
- Patients may have had single blips in viral load to greater than 50 but less than 1000 copies/ml within the year prior to screening.
- Current Substance profile by chart review or phone screening:
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- Marijuana use defined as marijuana use by any route at least 3 times per week in the absence of tobacco. N= 20.
- Tobacco use only based on report of regular (at least 3 times per week smoking). N=24
- Tobacco plus marijuana use defined as regular smoking and marijuana (at least 3 times per week) N =7
- No substance use of any type (alcohol, tobacco, marijuana or other recreational drugs in the past 90 days). N = 10
- Able to provide written informed consent in English and to adhere to protocol schedule
Who cannot join
- History of AIDS defining illness
- Pregnancy at any time during the study
- Use of substances that would interfere with the ability to complete the study
- History of significant cognitive or motor impairment or other chronic condition that would interfere with the ability to complete the study and impact neurocognitive testing
- Acute psychiatric symptoms (e.g. suicidality, mania, psychosis or severe depression)
- Other neurological disorder (e.g. multiple sclerosis, seizure disorder, etc.) requiring ongoing treatment or active outpatient evaluation
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- Severe mental illness (requiring antipsychotic or mood stabilizing medications and/or inpatient hospitalization in past year)
- History of CNS infection (AIDS opportunistic (e.g. toxoplasmosis) or non-opportunistic (bacterial meningitis) with lasting or permanent neurological sequelae)
- Underlying and/or uncontrolled medical illnesses that may result in chronic inflammation , (e.g. SLE or autoimmune disease) as determined by the PI
- Nursing mothers
- Unable to read and write in English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke UMC
Durham, North Carolina, 27710
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Consequences of Marijuana Use on Inflammatory Pathways in HIV-Infected Youth
Proposed study focuses on Youth With HIV (YWH) recruited from the University of North Carolina using a cross sectional assessment of blood samples, clinical, demographic, behavioral, [including substance use and frequency], and neurocognitive data will be evaluated from YWH treated before CD4 T cell decline.
Read the detailed description
The long-term goal for the proposed research is to apply a systems biology approach to discover evidence that provides the basis for understanding the complex and at times conflicting roles for marijuana in chronic inflammation in HIV-infected youth. To achieve the goal, a systems biology approach with two aims is designed:
Aim 1. To identify inflammatory immune pathways perturbed by recreational marijuana with or without concomitant use of tobacco products by applying a deep sequencing approach to define global transcriptome of peripheral blood cells from HIV-infected virally suppressed youth.
Aim 2. To develop biomarker profiles associated with pro- or anti-inflammatory pathways perturbed by marijuana and to discover biomarker profiles linked to neurocognitive impairment that are impacted by marijuana and tobacco use by YWH
- Conditions
- Youth With HIV
- Keywords
- substance use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV infected youth who use marijuana only | Not described | |
| HIV infected youth who use tobacco only | Not described | |
| HIV infected youth who use tobacco and marijuana | Not described | |
| HIV infected youth with no substance use | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bio-marker pathways that are abnormal.
This is measured by molecular mechanism of chronic macrophage activation.
Measured: 24 months
Plasma levels of sCD163
Chi-square test will be used to compare discrete variables
Measured: 24 months
Neurocognitive function as measured by Trial Making Test (TMT)
Measured: 24 months
Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate)
Measured: 24 months
Neurocognitive function as measured by Hopkins Verbal Learning Test-R
Measured: 24 months
Neurocognitive function as measured by the Brief Visuospatial Memory Test-R
Measured: 24 months
Neurocognitive function as measured by the WRAT-4 Word Reading subtest
Measured: 24 months
Neurocognitive function as measured by Activities of Daily Living Questionnaire
Measured: 24 months
Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning
Measured: 24 months
Neurocognitive function as measured by Grooved Pegboard test
Measured: 24 months
Neurocognitive function as measured by Timed Gait Test
Measured: 24 months
Neurocognitive function as measured by Verbal Fluency Test
Measured: 24 Months
Neurocognitive function as measured by Brief Symptom Inventory
Measured: 24 months
Neurocognitive function as measured by Beck Depression Inventory-II
Measured: 24 months
Neurocognitive function as measured by ASSIST (substance abuse)
Measured: 24 months
Neurocognitive function as measured by Base ATN Adherence Questions
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start31 Oct 2019
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Youth With HIVStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- John W sleasman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927053
- Sponsor's protocol ID
- Pro00100780
- Status last verified
- Nov 2023
- First submitted
- 23 Apr 2019
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Marijuana Use on Inflammatory Pathways in HIV-Infected Youth
- ClinicalTrials.gov ID
- NCT03927053
- Acronym / sponsor ID
- Pro00100780
- Conditions
- Youth With HIV
- Keywords
- substance use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 25 Apr 2019 (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.
Proposed study focuses on Youth With HIV (YWH) recruited from the University of North Carolina using a cross sectional assessment of blood samples, clinical, demographic, behavioral, [including substance use and frequency], and neurocognitive data will be evaluated from YWH treated before CD4 T cell decline.
Detailed description
The long-term goal for the proposed research is to apply a systems biology approach to discover evidence that provides the basis for understanding the complex and at times conflicting roles for marijuana in chronic inflammation in HIV-infected youth. To achieve the goal, a systems biology approach with two aims is designed:
Aim 1. To identify inflammatory immune pathways perturbed by recreational marijuana with or without concomitant use of tobacco products by applying a deep sequencing approach to define global transcriptome of peripheral blood cells from HIV-infected virally suppressed youth.
Aim 2. To develop biomarker profiles associated with pro- or anti-inflammatory pathways perturbed by marijuana and to discover biomarker profiles linked to neurocognitive impairment that are impacted by marijuana and tobacco use by YWH
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV infected youth who use marijuana only | – | – |
| HIV infected youth who use tobacco only | – | – |
| HIV infected youth who use tobacco and marijuana | – | – |
| HIV infected youth with no substance use | – | – |
Who may qualify
- Ages
- 21 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Enrollment will consist of approximately 61 HIV-infected youth meeting the below entry criteria who are receiving antiretroviral therapy with undetectable viral levels at the time of entry (based on viral load assay within 1 year of enrollment) Recruitment will include Youth Age 21-28 * Youth who use marijuana only [targeted number 20 participants] * Youth who use tobacco products only [targeted number 24 participants] * Youth who use marijuana and tobacco [targeted number 7 participants] * Youth who do not use substances [targeted number 10 participants]
Key inclusion criteria (11 listed)
- Age 21 years 0 days - less than28 years 364 days
- Currently treated with stable ART and no ART changes for >6months.
- Willingness to participate in CASI questionnaire of self-reported substance use
- Documented behavioral transmission of HIV infection based on CLIA approved HIV antibody/antigen based testing method in medical record -HIV diagnosis greater than or equal to years. Viral load LESS THAN 50 COPIES/ML for the past 6 months. --
- Patients may have had single blips in viral load to greater than 50 but less than 1000 copies/ml within the year prior to screening.
Key exclusion criteria (11 listed)
- History of AIDS defining illness
- Pregnancy at any time during the study
- Use of substances that would interfere with the ability to complete the study
- History of significant cognitive or motor impairment or other chronic condition that would interfere with the ability to complete the study and impact neurocognitive testing
- Acute psychiatric symptoms (e.g. suicidality, mania, psychosis or severe depression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of bio-marker pathways that are abnormal.
Time frame: 24 months
This is measured by molecular mechanism of chronic macrophage activation.
Plasma levels of sCD163
Time frame: 24 months
Chi-square test will be used to compare discrete variables
Neurocognitive function as measured by Trial Making Test (TMT)
Time frame: 24 months
Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate)
Time frame: 24 months
Neurocognitive function as measured by Hopkins Verbal Learning Test-R
Time frame: 24 months
Neurocognitive function as measured by the Brief Visuospatial Memory Test-R
Time frame: 24 months
Neurocognitive function as measured by the WRAT-4 Word Reading subtest
Time frame: 24 months
Neurocognitive function as measured by Activities of Daily Living Questionnaire
Time frame: 24 months
Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning
Time frame: 24 months
Neurocognitive function as measured by Grooved Pegboard test
Time frame: 24 months
Neurocognitive function as measured by Timed Gait Test
Time frame: 24 months
Neurocognitive function as measured by Verbal Fluency Test
Time frame: 24 Months
Neurocognitive function as measured by Brief Symptom Inventory
Time frame: 24 months
Neurocognitive function as measured by Beck Depression Inventory-II
Time frame: 24 months
Neurocognitive function as measured by ASSIST (substance abuse)
Time frame: 24 months
Neurocognitive function as measured by Base ATN Adherence Questions
Time frame: 24 months
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 13 Nov 2023.
- 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.
John W sleasman, MD principal investigator
Duke University
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 Youth With HIV, run by Duke University 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 11 inclusion and 11 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 13 Nov 2023. 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?
Number of bio-marker pathways that are abnormal. (time frame: 24 months). The study lists 16 primary outcomes in all. 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 13 Nov 2023.