Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03976258 |
Recruitment Status :
Recruiting
First Posted : June 5, 2019
Last Update Posted : November 13, 2020
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Condition or disease | Intervention/treatment |
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HIV Infection Opioid-use Disorder Cardiovascular Diseases | Drug: buprenorphine/naloxone Drug: Methadone Drug: Naltrexone Injection Drug: Heroin |
Study Type : | Observational |
Estimated Enrollment : | 180 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV |
Actual Study Start Date : | July 14, 2017 |
Estimated Primary Completion Date : | May 31, 2022 |
Estimated Study Completion Date : | May 31, 2022 |
Group/Cohort | Intervention/treatment |
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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.
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Drug: Heroin
This is an observational study. Participants using heroin will be enrolled into this group. |
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.
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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.
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Drug: buprenorphine/naloxone
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. |
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.
|
Drug: buprenorphine/naloxone
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. |
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
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Drug: Methadone
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. |
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.
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Drug: Naltrexone Injection
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.
Other Name: Vivitrol |
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.
|
Drug: Methadone
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. |
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.
|
Drug: Naltrexone Injection
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.
Other Name: Vivitrol |
- 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
- Change in total fat stores measured by Whole body Dual-energy X-ray absorptiometry [ Time Frame: 48 weeks ]Measurement of fat stores
- Change in aortofemoral pulse wave velocity [ Time Frame: 48 weeks ]Measure of arterial stiffness
- Change is waist to hip ratio [ Time Frame: 48 weeks ]Measurement of central obesity
- Change in body mass index [ Time Frame: 48 weeks ]Body measurement
Biospecimen Retention: Samples Without DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Active infection, malignancy or other inflammatory condition
- Uncontrolled diabetes or hypothyroidism
- Known cardiovascular disease
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976258
Contact: Cheryl A Smith, BA | 216-778-7141 | csmith@metrohealth.org | |
Contact: Danielle Labbato, RN | 216-844-2739 | Danielle.Labbato@UHhospitals.org |
United States, Ohio | |
University Hospitals Cleveland Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Danielle Labbato, RN 216-844-2739 danielle.labbato@UHhospitals.org | |
Metrohealth Medical center | Recruiting |
Cleveland, Ohio, United States, 44109 | |
Contact: Cheryl Smith, BA 216-778-7141 csmith15@metrohealth.org |
Principal Investigator: | Corrilynn O Hileman, MD | MetroHealth Medical Center | |
Principal Investigator: | Grace A McComsey, MD | University Hospitals Cleveland Medical Center |
Responsible Party: | Corrilynn Hileman, Principal Investigator, MetroHealth Medical Center |
ClinicalTrials.gov Identifier: | NCT03976258 |
Other Study ID Numbers: |
IRB17-00336 and IRB17-00429 1R01DA044576-01 ( U.S. NIH Grant/Contract ) |
First Posted: | June 5, 2019 Key Record Dates |
Last Update Posted: | November 13, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
heroin HIV inflammation cardiovascular |
Cardiovascular Diseases Naltrexone Buprenorphine Methadone Buprenorphine, Naloxone Drug Combination Heroin Naloxone Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists Alcohol Deterrents Antitussive Agents Respiratory System Agents |