Management of Hepatitis C in HIV Infected Injection Drug Users (IDUs)
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ClinicalTrials.gov Identifier: NCT01448915 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 7, 2011
Last Update Posted
: August 21, 2017
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Condition or disease |
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HIV Infection Hepatitis C |
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Management of Hepatitis C in HIV Infected IDUs |
Study Start Date : | September 2009 |
Estimated Primary Completion Date : | March 2019 |
Estimated Study Completion Date : | March 2019 |
Group/Cohort |
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Persons with HIV and HCV coinfection
Persons with HIV and HCV coinfection who receive medical care for HIV infection at Johns Hopkins Hospital
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- Hepatitis C Treatment Uptake and HCV cure [ Time Frame: 5 years ]The proportion of persons with HIV and HCV coinfection who achieve HCV cure
- Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure [ Time Frame: 5 years ]Clinical events including liver failure and liver cancer
- Liver stiffness measurement by elastography in persons with HIV infection [ Time Frame: 5 years ]Change in liver stiffness following HCV cure
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Current or prior drug use
- Reactive HCV antibody
- Reactive HIV antibody
Exclusion Criteria:
- Women may not undergo FibroScan while pregnant
- Persons with implanted cardiac devices may not undergo FibroScan

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): NCT01448915
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Mark S. Sulkowski, MD | Johns Hopkins University |
Publications of Results:
Other Publications:
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01448915 History of Changes |
Obsolete Identifiers: | NCT00496912 |
Other Study ID Numbers: |
NA00029706 R01DA016065 ( U.S. NIH Grant/Contract ) |
First Posted: | October 7, 2011 Key Record Dates |
Last Update Posted: | August 21, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Johns Hopkins University:
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 |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C HIV Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |