Status:
COMPLETED
HCV/HIV Coinfection: Antiviral Therapy and Fibrosis
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infection
Hepatitis C
Eligibility:
All Genders
18-99 years
Brief Summary
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...
Detailed Description
Enrolled subjects will complete questionnaires concerning health status, lifestyle, and alcohol/drug use. Participants will undergo liver elastography every 6-12 months.
Eligibility Criteria
Inclusion
- Co-Infected Arm
- 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.
- Subject must receive medical care at the JHU HIV clinic or through the Viral Hepatitis Center.
- Subjects previously enrolled in the study cohort, but not currently receiving care in the Moore Clinic, may continue in the study.
- Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
- Subject must be able to provide informed written consent.
- Control Arm
- 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.
- Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
- Subject must be able to provide informed written consent.
Exclusion
- 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.
- 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.
- To avoid unknown risks, subjects with an implanted cardiac device such as a defibrillator or pacemaker may not undergo FibroScan.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT01423643
Start Date
March 1 2001
End Date
October 1 2015
Last Update
February 24 2016
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287