HIV InfectionNCT03976258
Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV
An observational study of HIV Infection and Opioid-use Disorder, run by MetroHealth Medical Center at 2 sites in United States.
Trial summary
Despite the advent of safer HIV therapies, high levels of markers of systemic inflammation and increased cardiovascular risk threaten the well-being of individuals living with HIV and present a significant challenge for HIV providers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infection, Opioid-use Disorder, Cardiovascular Diseases
- What is being tested?
- buprenorphine/naloxone, Methadone and Naltrexone Injection
- Type of treatment
- Injection or infusion
- How many people
- 190 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2017to 31 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults ages 18 to 80 years with and without HIV infection using heroin or initiating treatment for heroin use or not using heroin.
Who may be able to join
- HIV infection or no HIV infection
- 18 years or older
- HIV-1 RNA < 400 if HIV-infected and on antiretroviral therapy
- On stable antiretroviral therapy at least 12 weeks with cumulative duration of at least a year for HIV-infected if on antiretroviral therapy
- Currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past for active heroin group
- Initiating medication assisted treatment for active heroin use initiating medication assisted treatment groups
Who cannot join
- Active infection, malignancy or other inflammatory condition
- Uncontrolled diabetes or hypothyroidism
- Known cardiovascular disease
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Metrohealth Medical center
Cleveland, Ohio, 44109
About this study
Official title: The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV
Despite the advent of safer HIV therapies, high levels of markers of systemic inflammation and increased cardiovascular risk threaten the well-being of individuals living with HIV and present a significant challenge for HIV providers. These risks may be accentuated in HIV-infected individuals who are active intravenous drug users (IVDU); however, this population has been specifically excluded from prior studies assessing immune activation and cardiovascular risk in people living with HIV. In this study, the investigators will specifically target HIV-infected participants who are active IVDU, and co-enroll a control group of HIV-infected participants who never used IV drugs. The investigators will study the specific alterations in immune activation and several mechanisms felt to be potential drivers of immune activation outside of the IVDU population, namely gut integrity alteration, microbial translocation, and oxidized lipids. The investigators will also study the effect of IVDU on markers of arterial inflammation and vascular function. Importantly, the investigators will study the reversibility of immune activation, gut dysfunction, and cardiovascular markers after cessation of IVDU, and to that effect, compare strategies for IVDU cessation-buprenorphine/naloxone versus methadone or vivitrol maintenance treatment.
Read the detailed description
This is a 48-week matched, prospective, observational, cohort study of HIV-infected adults on antiretroviral therapy who actively use heroin or who have never used heroin. The overarching goals are 1) to define the extent and specifics of immune activation in HIV-infected IV heroin users; 2) to define the effect of IV heroin on gut integrity and permeability, and the relationship of gut integrity alteration and immune activation; 3) importantly, to study the reversibility of immune activation, inflammation, and gut dysfunction after cessation of IV heroin, and to that effect, compare strategies for medication assisted treatment-buprenorphine/naloxone versus methadone or vivitrol maintenance; 4) to study if heightened immune activation associated with active intravenous drug use (IVDU) is associated with higher cardiovascular disease risk, including endothelial dysfunction and arterial inflammation, and if these effects are reversible with buprenorphine/naloxone or methadone.
- Conditions
- HIV Infection, Opioid-use Disorder, Cardiovascular Diseases
- Being tested
- buprenorphine/naloxone, Methadone, Naltrexone Injection, Heroin
- Keywords
- heroin, HIV, inflammation, cardiovascular
- Medical subject headings
- HIV Infections, Opioid-Related Disorders, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buprenorphine/naloxoneDrug
This is an observational study. Buprenorphine/naloxone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.
MethadoneDrug
This is an observational study. Methadone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.
Naltrexone InjectionDrug
Also called Vivitrol
This is an observational study. Naltrexone injection for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.
HeroinDrug
This is an observational study. Participants using heroin will be enrolled into this group.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected adults actively using heroin | HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past. Receives: Drug: Heroin | |
| HIV-infected adults never having used heroin | HIV-infected adults on antiretroviral therapy matched to HIV-infected adults actively using heroin by age, sex and CD4+ count. | |
| HIV-infected adults initiating buprenorphine/naloxone | HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with buprenorphine/naloxone. Receives: Drug: buprenorphine/naloxone | |
| HIV-uninfected adults initiating buprenorphine/naloxone | HIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with buprenorphine/naloxone. Receives: Drug: buprenorphine/naloxone | |
| HIV-infected adults initiating methadone | HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with methadone Receives: Drug: Methadone | |
| HIV-infected adults initiating Vivitrol | HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with Vivitrol. Receives: Drug: Naltrexone Injection | |
| HIV-uninfected adults initiating methadone | HIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with methadone. Receives: Drug: Methadone | |
| HIV-uninfected adults initiating Vivitrol | HIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with Vivitrol. Receives: Drug: Naltrexone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma soluble CD14 concentration
soluble marker of monocyte activation
Measured: 48 weeks
Change in Endopat measure of microvascular function
Measure of endothelial function
Measured: 48 weeks
Change in target to background ratio measured by fluorodeoxyglucose (FDG)-positron emission tomography (PET)
Measure of vascular inflammation
Measured: 48 weeks
Change in plasma Interferon Gamma-Induced Protein 10 concentration
soluble marker of inflammation
Measured: 48 weeks
Change in plasma intestinal fatty acid binding protein concentration
soluble marker of gut integrity
Measured: 48 weeks
Secondary outcomes (4)
Change in total fat stores measured by Whole body Dual-energy X-ray absorptiometry
Measurement of fat stores
Measured: 48 weeks
Change in aortofemoral pulse wave velocity
Measure of arterial stiffness
Measured: 48 weeks
Change is waist to hip ratio
Measurement of central obesity
Measured: 48 weeks
Change in body mass index
Body measurement
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start14 Jul 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Corrilynn Hileman, MetroHealth Medical Center
- Investigators
- Corrilynn O Hileman, MD, Principal investigator, MetroHealth Medical CenterGrace A McComsey, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976258
- Sponsor's protocol ID
- IRB17-00336 and IRB17-00429
- Other IDs
- 1R01DA044576-01
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2018
- Last updated
- 2 Oct 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 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV
- ClinicalTrials.gov ID
- NCT03976258
- Acronym / sponsor ID
- IRB17-00336 and IRB17-00429
- Conditions
- HIV Infection, Opioid-use Disorder, Cardiovascular Diseases
- Keywords
- heroin, HIV, inflammation, cardiovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jun 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.
Despite the advent of safer HIV therapies, high levels of markers of systemic inflammation and increased cardiovascular risk threaten the well-being of individuals living with HIV and present a significant challenge for HIV providers. These risks may be accentuated in HIV-infected individuals who are active intravenous drug users (IVDU); however, this population has been specifically excluded from prior studies assessing immune activation and cardiovascular risk in people living with HIV. In this study, the investigators will specifically target HIV-infected participants who are active IVDU, and co-enroll a control group of HIV-infected participants who never used IV drugs. The investigators will study the specific alterations in immune activation and several mechanisms felt to be potential drivers of immune activation outside of the IVDU population, namely gut integrity alteration, microbial translocation, and oxidized lipids. The investigators will also study the effect of IVDU on markers of arterial inflammation and vascular function. Importantly, the investigators will study the reversibility of immune activation, gut dysfunction, and cardiovascular markers after cessation of IVDU, and to that effect, compare strategies for IVDU cessation-buprenorphine/naloxone versus methadone or vivitrol maintenance treatment.
Detailed description
This is a 48-week matched, prospective, observational, cohort study of HIV-infected adults on antiretroviral therapy who actively use heroin or who have never used heroin. The overarching goals are 1) to define the extent and specifics of immune activation in HIV-infected IV heroin users; 2) to define the effect of IV heroin on gut integrity and permeability, and the relationship of gut integrity alteration and immune activation; 3) importantly, to study the reversibility of immune activation, inflammation, and gut dysfunction after cessation of IV heroin, and to that effect, compare strategies for medication assisted treatment-buprenorphine/naloxone versus methadone or vivitrol maintenance; 4) to study if heightened immune activation associated with active intravenous drug use (IVDU) is associated with higher cardiovascular disease risk, including endothelial dysfunction and arterial inflammation, and if these effects are reversible with buprenorphine/naloxone or methadone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HIV-infected adults actively using heroin | – | Drug: HeroinHIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past. |
| HIV-infected adults never having used heroin | – | –HIV-infected adults on antiretroviral therapy matched to HIV-infected adults actively using heroin by age, sex and CD4+ count. |
| HIV-infected adults initiating buprenorphine/naloxone | – | Drug: buprenorphine/naloxoneHIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with buprenorphine/naloxone. |
| HIV-uninfected adults initiating buprenorphine/naloxone | – | Drug: buprenorphine/naloxoneHIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with buprenorphine/naloxone. |
| HIV-infected adults initiating methadone | – | Drug: MethadoneHIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with methadone |
| HIV-infected adults initiating Vivitrol | – | Drug: Naltrexone InjectionHIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with Vivitrol. |
| HIV-uninfected adults initiating methadone | – | Drug: MethadoneHIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with methadone. |
| HIV-uninfected adults initiating Vivitrol | – | Drug: Naltrexone InjectionHIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with Vivitrol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ages 18 to 80 years with and without HIV infection using heroin or initiating treatment for heroin use or not using heroin.
Key inclusion criteria (6 listed)
- HIV infection or no HIV infection
- 18 years or older
- HIV-1 RNA < 400 if HIV-infected and on antiretroviral therapy
- On stable antiretroviral therapy at least 12 weeks with cumulative duration of at least a year for HIV-infected if on antiretroviral therapy
- Currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past for active heroin group
Key exclusion criteria (4 listed)
- Active infection, malignancy or other inflammatory condition
- Uncontrolled diabetes or hypothyroidism
- Known cardiovascular disease
- Pregnancy
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 |
|---|---|---|
| buprenorphine/naloxoneThis is an observational study. Buprenorphine/naloxone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs. | Drug | HIV-infected adults initiating buprenorphine/naloxone, HIV-uninfected adults initiating buprenorphine/naloxone |
| MethadoneThis is an observational study. Methadone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs. | Drug | HIV-infected adults initiating methadone, HIV-uninfected adults initiating methadone |
| Naltrexone InjectionAlso: VivitrolThis is an observational study. Naltrexone injection for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs. | Drug | HIV-infected adults initiating Vivitrol, HIV-uninfected adults initiating Vivitrol |
| HeroinThis is an observational study. Participants using heroin will be enrolled into this group. | Drug | HIV-infected adults actively using heroin |
Primary outcome
Change in plasma soluble CD14 concentration
Time frame: 48 weeks
soluble marker of monocyte activation
Change in Endopat measure of microvascular function
Time frame: 48 weeks
Measure of endothelial function
Change in target to background ratio measured by fluorodeoxyglucose (FDG)-positron emission tomography (PET)
Time frame: 48 weeks
Measure of vascular inflammation
Change in plasma Interferon Gamma-Induced Protein 10 concentration
Time frame: 48 weeks
soluble marker of inflammation
Change in plasma intestinal fatty acid binding protein concentration
Time frame: 48 weeks
soluble marker of gut integrity
4 secondary outcomes
Change in total fat stores measured by Whole body Dual-energy X-ray absorptiometry
Time frame: 48 weeks
Change in aortofemoral pulse wave velocity
Time frame: 48 weeks
Change is waist to hip ratio
Time frame: 48 weeks
Change in body mass index
Time frame: 48 weeks
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 2 Oct 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.
Corrilynn O Hileman, MD principal investigator
MetroHealth Medical Center
Grace A McComsey, MD principal investigator
University Hospitals Cleveland Medical Center
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 Infection and Opioid-use Disorder, run by MetroHealth Medical Center 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 6 inclusion and 4 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 2 Oct 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?
Change in plasma soluble CD14 concentration (time frame: 48 weeks). The study lists 5 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 2 Oct 2023.