We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

HCV/HIV Coinfection: Antiviral Therapy and Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01423643
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : February 24, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Thomas, Johns Hopkins University

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 study liver disease progression in a cohort of dually infected persons according to the success of ART.

Condition or disease
HIV Infection 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.

Study Type : Observational
Actual Enrollment : 1250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HCV/HIV Coinfection: Antiviral Therapy and Fibrosis
Study Start Date : March 2001
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Fibrosis stage [ Time Frame: up to 15 years ]
    Liver histologic fibrosis stage (Ishak 0 - 6)

Secondary Outcome Measures :
  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

Biospecimen Retention:   Samples Without DNA
Frozen serum and plasma samples. Liver biopsy fixed slides.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423643

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: David L. Thomas, MD Johns Hopkins University


Responsible Party: David Thomas, Chief, Infectious Diseases, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01423643     History of Changes
Other Study ID Numbers: NA00033421
R01DA013806 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Keywords provided by David Thomas, Johns Hopkins University:
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:
Hepatitis C
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Parasitic Diseases
Antiviral Agents
Anti-Infective Agents