HCV/HIV Coinfection: Antiviral Therapy and Fibrosis



Status:Completed
Conditions:HIV / AIDS, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:March 2001
End Date:October 2015

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The chief purpose of this research is to understand how antiretroviral therapy (ART) affects
progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV).
The investigators study liver disease progression in a cohort of dually infected persons
according to the success of ART.

Enrolled subjects will complete questionnaires concerning health status, lifestyle, and
alcohol/drug use. Participants will undergo liver elastography every 6-12 months.

Inclusion Criteria:

Co-Infected Arm

1. Subject must be an HIV/HCV co-infected adult with HIV infection diagnosed by antibody
testing and chronic HCV infection diagnosed by reactive HCV antibody and detectable
plasma HCV RNA.

2. Subject must receive medical care at the JHU HIV clinic or through the Viral
Hepatitis Center.

3. Subjects previously enrolled in the study cohort, but not currently receiving care in
the Moore Clinic, may continue in the study.

4. Females of childbearing potential must be willing to undergo a urine or serum
pregnancy test.

5. Subject must be able to provide informed written consent.

Control Arm

1. Subject must have or be at risk of having medical conditions that increase the risk
of liver disease. These include, but are not limited to, HIV mono-infection, HCV
mono-infection, Hepatitis B infection, alcohol addiction, and/or non-alcoholic
steatohepatitis.

2. Females of childbearing potential must be willing to undergo a urine or serum
pregnancy test.

3. Subject must be able to provide informed written consent.

Exclusion Criteria:

1. To avoid risks associated with ionizing radiation, female subjects may not be
pregnant or breast feeding at the time of DEXA scanning. To avoid unknown risks to
the fetus, female subjects may not be pregnant at the time of liver biopsy or
FibroScan.

2. To avoid interference with the DEXA scan, the subject may not have undergone a
nuclear medicine exam with the past week and/or may not have undergone an x-ray
procedure with contrast solution within the past 72 hours.

3. To avoid unknown risks, subjects with an implanted cardiac device such as a
defibrillator or pacemaker may not undergo FibroScan.
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1
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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