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OpenTrials
Completed

NCT Number: NCT01423643

HCV/HIV Coinfection: Antiviral Therapy and Fibrosis

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Fibrosis stage

    Time frame: up to 15 years

    Liver histologic fibrosis stage (Ishak 0 - 6)

Secondary outcomes

  1. Body composition

    Time frame: up to 15 years

    Body composition measurements, derived from DEXA

  2. Liver stiffness

    Time frame: up to 15 years

    Liver stiffness, derived from liver elastography

  3. Serum markers

    Time frame: up to 15 years

    Serum levels of various chemical markers

  4. Liver histology

    Time frame: up to 15 years

    Liver histology as described by a pathologist

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2001
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2011
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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