HIV (Human Immunodeficiency Virus)SPISENCT07461350
Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV
An observational study of HIV (Human Immunodeficiency Virus), run by University of California, San Francisco at 4 sites in United States.
Trial summary
This observational research study is studying how substance use impacts scarring and inflammation of the heart. This study involves one study visit for a cardiac MRI. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Aug 2026to 31 Mar 2030
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with and without HIV enrolled in the MACS/WIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites
Who may be able to join
- Participants with and without HIV enrolled in the MACS/WIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites
Who cannot join
- Standard contraindications to MRI
- claustrophobia,
- metal implants,
- large body size (weight >350 lbs or abdominal sagittal diameter >70 cm),
- pregnancy)
- Gadolinium risk
Show all 10Show fewer
- severe or uncontrolled asthma,
- visit day eGFR<45 ml/min/1.73 m2;
- poor venous access
- pregnancy or lactation
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Emory University, School of Medicine
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21218
University of California, San Francisco
San Francisco, California, 94115
Albert Einstein College of Medicine
The Bronx, New York, 10462
About this study
Official title: Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV (SPISE)
This observational research study is studying how substance use impacts scarring and inflammation of the heart. This study involves one study visit for a cardiac MRI.
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- HIV, cardiac MRI, stimulant use
- Medical subject headings
- Acquired Immunodeficiency Syndrome
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 |
|---|---|---|
| Current Stimulant Use | Used stimulants (amphetamines, cocaine, etc.) in past year | |
| Past Stimulant Use | Previously used stimulants (amphetamines, cocaine, etc.) but not in the last 12 months | |
| No Stimulant use | Never used stimulants (amphetamines, cocaine, etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac MRI
CMR assessments to provide detailed myocardial characterization (e.g. diffuse inflammation (nT1), myocardial fibrosis (ECV), and myocardial scar assessed using LGE)
Measured: Visit 1, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start5 Aug 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Phyllis Tien, MD, Principal investigator, University of California, San FranciscoElise Riley, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461350
- Sponsor's protocol ID
- 25-44397
- Other IDs
- 1RM1DA063351
- Acronym
- SPISE
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data for MWCCS research participants are available from the JHU Institutional data repository managed by the MWCCS Data Analysis and Sharing Center (DASC) by submission of a Concept Sheet at https://statepi.jhsph.edu/mwccs/work-with-us/
Publications
Riley ED, Vittinghoff E, Wu AHB, Coffin PO, Hsue PY, Kazi DS, Wade A, Braun C, Lynch KL. Impact of polysubstance use on high-sensitivity cardiac troponin I over time in homeless and unstably housed women. Drug Alcohol Depend. 2020 Dec 1;217:108252. doi: 10.1016/j.drugalcdep.2020.108252. Epub 2020 Aug 30.
PubMed 32919207Riley ED, Kizer JR, Tien PC, Vittinghoff E, Lynch KL, Wu AHB, Coffin PO, Beck-Engeser G, Braun C, Hunt PW. Multiple substance use, inflammation and cardiac stretch in women living with HIV. Drug Alcohol Depend. 2022 Sep 1;238:109564. doi: 10.1016/j.drugalcdep.2022.109564. Epub 2022 Jul 8.
PubMed 35872529
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV (SPISE)
- ClinicalTrials.gov ID
- NCT07461350
- Acronym / sponsor ID
- SPISE / 25-44397
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- HIV, cardiac MRI, stimulant use
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 10 Mar 2026 (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 observational research study is studying how substance use impacts scarring and inflammation of the heart. This study involves one study visit for a cardiac MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Current Stimulant Use | – | –Used stimulants (amphetamines, cocaine, etc.) in past year |
| Past Stimulant Use | – | –Previously used stimulants (amphetamines, cocaine, etc.) but not in the last 12 months |
| No Stimulant use | – | –Never used stimulants (amphetamines, cocaine, etc.) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with and without HIV enrolled in the MACS/WIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites
Key inclusion criteria (1 listed)
- Participants with and without HIV enrolled in the MACS/WIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites
Key exclusion criteria (10 listed)
- Standard contraindications to MRI
- claustrophobia,
- metal implants,
- large body size (weight >350 lbs or abdominal sagittal diameter >70 cm),
- pregnancy)
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
Cardiac MRI
Time frame: Visit 1, up to 2 hours
CMR assessments to provide detailed myocardial characterization (e.g. diffuse inflammation (nT1), myocardial fibrosis (ECV), and myocardial scar assessed using LGE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 32919207Riley ED, Vittinghoff E, Wu AHB, Coffin PO, Hsue PY, Kazi DS, Wade A, Braun C, Lynch KL. Impact of polysubstance use on high-sensitivity cardiac troponin I over time in homeless and unstably housed women. Drug Alcohol Depend. 2020 Dec 1;217:108252. doi: 10.1016/j.drugalcdep.2020.108252. Epub 2020 Aug 30.
- Background: PubMed 35872529Riley ED, Kizer JR, Tien PC, Vittinghoff E, Lynch KL, Wu AHB, Coffin PO, Beck-Engeser G, Braun C, Hunt PW. Multiple substance use, inflammation and cardiac stretch in women living with HIV. Drug Alcohol Depend. 2022 Sep 1;238:109564. doi: 10.1016/j.drugalcdep.2022.109564. Epub 2022 Jul 8.
- Individual participant dataSharing planned: No. data for MWCCS research participants are available from the JHU Institutional data repository managed by the MWCCS Data Analysis and Sharing Center (DASC) by submission of a Concept Sheet at https://statepi.jhsph.edu/mwccs/work-with-us/
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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.
Phyllis Tien, MD principal investigator
University of California, San Francisco
Elise Riley, PhD principal investigator
University of California, San Francisco
4 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 (Human Immunodeficiency Virus), run by University of California, San Francisco at 4 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 1 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
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?
Cardiac MRI (time frame: Visit 1, up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07461350, which also lists 2 linked publications.
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 11 Aug 2026.