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
  Purpose

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.


Condition
HIV Infection
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HCV/HIV Coinfection: Antiviral Therapy and Fibrosis

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Fibrosis stage [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]
    Liver histologic fibrosis stage (Ishak 0 - 6)


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

Frozen serum and plasma samples. Liver biopsy fixed slides.


Estimated Enrollment: 1250
Study Start Date: March 2001
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423643

Contacts
Contact: Rosie Silva 410-502-7134 rsilva6@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: David L. Thomas, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: David L. Thomas, MD Johns Hopkins University
  More Information

Publications:

Responsible Party: David Thomas, Chief, Infectious Diseases, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01423643     History of Changes
Other Study ID Numbers: NA00033421, R01DA013806
Study First Received: August 23, 2011
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

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:
HIV Infections
Acquired Immunodeficiency Syndrome
Fibrosis
Hepatitis
Hepatitis A
Hepatitis C
Coinfection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Infection
Parasitic Diseases
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014