HIV InfectionNCT01448915
Management of Hepatitis C in HIV Infected Injection Drug Users (IDUs)
An observational study of HIV Infection and Hepatitis C, run by Johns Hopkins University at 1 site in United States.
Trial summary
The principal goal of this research project is to evaluate the natural history of HCV and liver disease and its treatment in HIV-infected persons who use drugs. Research procedures will focus on determining liver disease prevalence and severity within this population. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- HIV Infection, Hepatitis C
- How many people
- 828 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 31 Mar 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective observational cohort of HIV-infected persons receiving medical care at the Johns Hopkins Hospital. Participants are eligible if they are HCV antibody positive and use or have used drugs.
Who may be able to join
- Current or prior drug use
- Reactive HCV antibody
- Reactive HIV antibody
Who cannot join
- Women may not undergo FibroScan while pregnant
- Persons with implanted cardiac devices may not undergo FibroScan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Hepatitis C in HIV Infected IDUs
The principal goal of this research project is to evaluate the natural history of HCV and liver disease and its treatment in HIV-infected persons who use drugs. Research procedures will focus on determining liver disease prevalence and severity within this population. This is an observational study without study specific interventions.
Read the detailed description
The principal goal of this research project is to evaluate the natural history of HCV and liver disease and its treatment in HIV-infected persons who use drugs. The recent availability of a novel, non-invasive method of measuring HCV disease stage makes it possible to test the relationship of HCV disease stage and the management of coinfected IDUs with adequate precision. The investigators will apply the innovative technology, elastography (FibroScan®) to ask whether the marked differences in the final disease outcome, end-stage liver disease (ESLD), can be explained by a measure of liver stiffness as assessed by elastography (FibroScan®). While advances in non-invasive disease assessment are critical to HCV management, the greatest challenge to improving HCV treatment effectiveness in coinfected persons remains low rates of treatment uptake and adherence, even when freely accessible. In response to this glaring disparity, the investigators will test potent behavioral reinforcement interventions to improve the management of HCV disease by adapting a rigorously studied contingent behavioral incentives program to the treatment to coinfected IDUs. Hepatitis C Treatment Eligibility: To determine the population prevalence of significant liver disease in coinfected IDUs using an innovative, non-invasive methodology (transient elastography, FibroScan®) to measure liver stiffness. Liver Disease Staging: To test the hypothesis that liver stiffness, assessed by a novel, non-invasive methodology, is predictive of the development of ESLD, defined as hepatic decompensation, hepatocellular cancer, and liver-related death, in coinfected IDUs.
- Conditions
- HIV Infection, Hepatitis C
- Keywords
- HIV, Human immunodeficiency virus, Acquired Immune Deficiency Syndrome Virus, AIDS virus, Immunodeficiency Virus, Human, Virus, Human Immunodeficiency, Hepatitis C, Hepatitis C, chronic, Hepatitis C virus, Hepatitis C antibodies, Hepatitis C antigens
- Medical subject headings
- HIV Infections, Hepatitis C, Acquired Immunodeficiency Syndrome, Hepatitis C, Chronic
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 |
|---|---|---|
| Persons with HIV and HCV coinfection | Persons with HIV and HCV coinfection who receive medical care for HIV infection at Johns Hopkins Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis C Treatment Uptake and HCV cure
The proportion of persons with HIV and HCV coinfection who achieve HCV cure
Measured: 5 years
Secondary outcomes (2)
Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure
Clinical events including liver failure and liver cancer
Measured: 5 years
Liver stiffness measurement by elastography in persons with HIV infection
Change in liver stiffness following HCV cure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study start31 Mar 2021
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- 828 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mark S. Sulkowski, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448915
- Sponsor's protocol ID
- NA_00029706
- Other IDs
- R01DA016065
- Status last verified
- Feb 2021
- First submitted
- 27 Sep 2011
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bilal U, Lau B, Lazo M, McCaul ME, Hutton HE, Sulkowski MS, Moore RD, Chander G. Interaction Between Alcohol Consumption Patterns, Antiretroviral Therapy Type, and Liver Fibrosis in Persons Living with HIV. AIDS Patient Care STDS. 2016 May;30(5):200-7. doi: 10.1089/apc.2016.0010.
PubMed 27158847Falade-Nwulia O, Sutcliffe C, Moon J, Chander G, Wansom T, Keruly J, Katzianer J, Nathanson A, Marks J, Mehta S, Thomas D, Moore R, Sulkowski M. High hepatitis C cure rates among black and nonblack human immunodeficiency virus-infected adults in an urban center. Hepatology. 2017 Nov;66(5):1402-1412. doi: 10.1002/hep.29308. Epub 2017 Oct 11.
PubMed 28608973Wansom T, Falade-Nwulia O, Sutcliffe CG, Mehta SH, Moore RD, Thomas DL, Sulkowski MS. Barriers to Hepatitis C Virus (HCV) Treatment Initiation in Patients With Human Immunodeficiency Virus/HCV Coinfection: Lessons From the Interferon Era. Open Forum Infect Dis. 2017 Feb 11;4(1):ofx024. doi: 10.1093/ofid/ofx024. eCollection 2017 Winter.
PubMed 28480293
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Hepatitis C in HIV Infected IDUs
- ClinicalTrials.gov ID
- NCT01448915
- Acronym / sponsor ID
- NA_00029706
- Conditions
- HIV Infection, Hepatitis C
- Keywords
- HIV, Human immunodeficiency virus, Acquired Immune Deficiency Syndrome Virus, AIDS virus, Immunodeficiency Virus, Human, Virus, Human Immunodeficiency, Hepatitis C, Hepatitis C, chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 828 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 7 Oct 2011 (estimated)
- 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.
The principal goal of this research project is to evaluate the natural history of HCV and liver disease and its treatment in HIV-infected persons who use drugs. Research procedures will focus on determining liver disease prevalence and severity within this population. This is an observational study without study specific interventions.
Detailed description
The principal goal of this research project is to evaluate the natural history of HCV and liver disease and its treatment in HIV-infected persons who use drugs. The recent availability of a novel, non-invasive method of measuring HCV disease stage makes it possible to test the relationship of HCV disease stage and the management of coinfected IDUs with adequate precision. The investigators will apply the innovative technology, elastography (FibroScan®) to ask whether the marked differences in the final disease outcome, end-stage liver disease (ESLD), can be explained by a measure of liver stiffness as assessed by elastography (FibroScan®). While advances in non-invasive disease assessment are critical to HCV management, the greatest challenge to improving HCV treatment effectiveness in coinfected persons remains low rates of treatment uptake and adherence, even when freely accessible. In response to this glaring disparity, the investigators will test potent behavioral reinforcement interventions to improve the management of HCV disease by adapting a rigorously studied contingent behavioral incentives program to the treatment to coinfected IDUs. Hepatitis C Treatment Eligibility: To determine the population prevalence of significant liver disease in coinfected IDUs using an innovative, non-invasive methodology (transient elastography, FibroScan®) to measure liver stiffness. Liver Disease Staging: To test the hypothesis that liver stiffness, assessed by a novel, non-invasive methodology, is predictive of the development of ESLD, defined as hepatic decompensation, hepatocellular cancer, and liver-related death, in coinfected IDUs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with HIV and HCV coinfection | – | –Persons with HIV and HCV coinfection who receive medical care for HIV infection at Johns Hopkins Hospital |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational cohort of HIV-infected persons receiving medical care at the Johns Hopkins Hospital. Participants are eligible if they are HCV antibody positive and use or have used drugs.
Key inclusion criteria (3 listed)
- Current or prior drug use
- Reactive HCV antibody
- Reactive HIV antibody
Key exclusion criteria (2 listed)
- Women may not undergo FibroScan while pregnant
- Persons with implanted cardiac devices may not undergo FibroScan
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
Hepatitis C Treatment Uptake and HCV cure
Time frame: 5 years
The proportion of persons with HIV and HCV coinfection who achieve HCV cure
2 secondary outcomes
Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure
Time frame: 5 years
Liver stiffness measurement by elastography in persons with HIV infection
Time frame: 5 years
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 21 Feb 2022.
- Background: PubMed 27158847Bilal U, Lau B, Lazo M, McCaul ME, Hutton HE, Sulkowski MS, Moore RD, Chander G. Interaction Between Alcohol Consumption Patterns, Antiretroviral Therapy Type, and Liver Fibrosis in Persons Living with HIV. AIDS Patient Care STDS. 2016 May;30(5):200-7. doi: 10.1089/apc.2016.0010.
- Results publication: PubMed 28608973Falade-Nwulia O, Sutcliffe C, Moon J, Chander G, Wansom T, Keruly J, Katzianer J, Nathanson A, Marks J, Mehta S, Thomas D, Moore R, Sulkowski M. High hepatitis C cure rates among black and nonblack human immunodeficiency virus-infected adults in an urban center. Hepatology. 2017 Nov;66(5):1402-1412. doi: 10.1002/hep.29308. Epub 2017 Oct 11.
- Results publication: PubMed 28480293Wansom T, Falade-Nwulia O, Sutcliffe CG, Mehta SH, Moore RD, Thomas DL, Sulkowski MS. Barriers to Hepatitis C Virus (HCV) Treatment Initiation in Patients With Human Immunodeficiency Virus/HCV Coinfection: Lessons From the Interferon Era. Open Forum Infect Dis. 2017 Feb 11;4(1):ofx024. doi: 10.1093/ofid/ofx024. eCollection 2017 Winter.
- Individual participant dataSharing planned: Undecided
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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.
Mark S. Sulkowski, MD principal investigator
Johns Hopkins University
1 site 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 Hepatitis C, run by Johns Hopkins University at 1 site 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 3 inclusion and 2 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 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Hepatitis C Treatment Uptake and HCV cure (time frame: 5 years). 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 NCT01448915, which also lists 3 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 21 Feb 2022.