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HCV/HIV Coinfection: Antiviral Therapy and Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Thomas, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01423643
First received: August 23, 2011
Last updated: February 13, 2013
Last verified: February 2013

August 23, 2011
February 13, 2013
March 2001
October 2014   (final data collection date for primary outcome measure)
Fibrosis stage [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]
Liver histologic fibrosis stage (Ishak 0 - 6)
Same as current
Complete list of historical versions of study NCT01423643 on ClinicalTrials.gov Archive Site
  • Body composition [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]
    Body composition measurements, derived from DEXA
  • Liver stiffness [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]
    Liver stiffness, derived from liver elastography
  • Serum markers [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]
    Serum levels of various chemical markers
  • Liver histology [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]
    Liver histology as described by a pathologist
Same as current
Not Provided
Not Provided
 
HCV/HIV Coinfection: Antiviral Therapy and Fibrosis
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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Frozen serum and plasma samples. Liver biopsy fixed slides.

Non-Probability Sample

Adults with HIV and Hepatitis C in the metropolitan Baltimore area. Preference given to those enrolled in the Johns Hopkins Infectious Diseases Outpatient Clinic.

  • HIV Infection
  • Hepatitis C
Not Provided
  • Main cohort
    Adults infected with both HIV and Hepatitis C
  • Control Group
    Adults at risk for liver disease, but not infected with both HIV and Hepatitis C

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1250
October 2014
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Rosie Silva 410-502-7134 rsilva6@jhmi.edu
United States
 
NCT01423643
NA00033421, R01DA013806
No
David Thomas, Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: David L. Thomas, MD Johns Hopkins University
Johns Hopkins University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP