Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection

April 16, 2024 updated by: National Institutes of Health Clinical Center (CC)

The Natural History of Liver Disease in a Cohort of Participants With Hepatitis B and/or Hepatitis C With or Without HIV Infection

Background:

- Hepatitis B and hepatitis C can cause liver damage. They can also cause serious illness, including liver cancer, and even death. This study will follow people who have hepatitis B or hepatitis C. The purpose is to understand more about how these viruses affect the immune system over the long term (up to 10 years). The study will also compare how these viruses affect people who do and do not have HIV, the virus that causes AIDS.

Objectives:

  • To do a long-term study of hepatitis B and hepatitis C infection.
  • To study the effects of hepatitis B and hepatitis C infection in people do and do not have HIV.

Eligibility:

- People at least 18 years of age who have hepatitis B or hepatitis C and have a regular doctor for their medical care.

Design:

  • Participants will be screened with a physical exam and medical history. Those who do not have a regular doctor to provide medical care during the study will not be able to take part.
  • Participants will have yearly visits with study researchers for up to 10 years. These tests will be done at each visit.
  • Medical history and physical exam.
  • Questionnaire (optional) on emotions, sexual behaviors, use of alcohol and drugs, and quality of life.
  • Blood and urine tests, including HIV testing.
  • Tissue sample collections for those who have had a liver or other tissue biopsy.
  • Participants may leave the study at any time. They will receive the standard of care from their regular doctor throughout the study....

Study Overview

Status

Completed

Conditions

Detailed Description

Chronic viral hepatitis is a major health problem affecting millions globally. The immunosuppressed population, especially those with HIV infection, remains at particular risk and the incidence of hepatocellular carcinoma (HCC) is increasing in the US and worldwide, with high rates in those who are cirrhotic, and is the 10th most common cause of death in the US.

HIV-hepatitis coinfection is problematic in that HIV patients are currently living longer on highly active antiretroviral therapy (HAART). Those who are coinfected with HBV and/or HCV progress more rapidly to cirrhosis and hepatic failure. Further research on the epidemiology, optimal screening and new therapeutic approaches in persons with advanced liver disease, in the setting of effective treatment for viral hepatitis is needed.

The primary objective of the proposed study is to characterize viral liver disease and factors affecting the natural history of viral liver disease in persons with and without HIV with an emphasis on those living in the Washington DC metropolitan area. The cohort will be designed to study research questions with respect to liver disease, disease pathogenesis using genomics, proteomics, and immunologic disease models. Secondary objectives include study of the immunopathogenesis of HBV and HCV disease progression in HIV infected subjects. In addition, this is an invaluable opportunity to determine the prevalence and risk factors associated with the development of hepatocellular carcinoma, the longterm effects of HCV clearance with DAAs, along with biomarker profile(s) for diagnosis and outcome. Moreover, this will serve as a catchment protocol to select appropriate participants for novel HBV and HCV therapeutic trials.

Study Type

Observational

Enrollment (Actual)

569

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • VA Medical Center, Washington D.C.
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

NIH NIAID Outpatient Clinic 8 Participants, local Washington DC Primary Clinics, and formerly the Washington DC VA Clnic

Description

  • INCLUSION CRITERIA:

To be eligible for participation on this protocol, a participant must satisfy all of the following conditions:

  1. Be greater than or equal to 18 years old
  2. HBV-infected and/or HCV-infected, or was HCV-infected and successfully treated
  3. Willing to undergo genetic testing
  4. Willingness to allow study staff to review your medical records between research visits
  5. Willing to have samples stored for future research
  6. Must have an identifiable primary care physician
  7. Willing to undergo HIV testing
  8. Childbearing female must test negative for pregnancy

An HBV infected individual is defined as any individual with documentation of the following:

- Positive Hepatitis B surface antigen within the past 12 months or HBV DNA positive, or prior documentation if the individual is currently on active therapy

An HCV infected individual is defined as any individual with documentation of the following in the past:

- Positive HCV antibody and/or positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater)

An HIV infected individual is defined as any individual with documentation of the following:

- Positive Enzyme Linked Immunosorbent Assay followed by a positive Western Blot or detectable HIV viral load or HIV viral less than 50 copies/mL with documentation this individuals is curently on an active HIV antiretroviral regimen.

EXCLUSION CRITERIA:

A participant will be ineligible to participate on this study if any of the following criteria are met:

  1. Unable to comply with research study visits
  2. Poor venous access
  3. Have any condition that the investigator considers a contraindication to study participation.
  4. Childbearing female with positive pregnancy test

Co-enrollment Guidelines: Participants may be enrolled in other protocols as long as the amount of research blood drawn does not exceed the acceptable NIH guidelines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
HBV and HCV Co-infection
Hepatitis B
Hepatitis B alone
Hepatitis C
Hepatitis C alone
HIV and HBV and HCV Tri-Infection
HIV and HBV Co-infection
HIV/HCV Co-Infection
HIV and HCV Co-infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of liver disease in patients with HCV
Time Frame: Annual visits
Exams and labs
Annual visits
Progression of liver disease in patients with HBV
Time Frame: Annual visits
exam and labs
Annual visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

Washington D.C. Veterans Affairs Medical Center

Investigators

  • Principal Investigator: Colleen M Hadigan, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2011

Study Registration Dates

First Submitted

May 7, 2011

First Submitted That Met QC Criteria

May 7, 2011

First Posted (Estimated)

May 10, 2011

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

December 19, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110152
  • 11-CC-0152

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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