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

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT01350648

Collaborator

Washington D.C. Veterans Affairs Medical Center (U.S. Fed)

569

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Hepatitis C HIV-HCV Co-Infection

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 Design

Study Type:

Observational

Actual Enrollment :

569 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 23, 2011

Arms and Interventions

Arm	Intervention/Treatment
HBV and HCV Co-infection 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 and HCV Tri-Infection
HIV and HBV Co-infection HIV and HBV Co-infection
HIV/HCV Co-Infection HIV and HCV Co-infection

Outcome Measures

Primary Outcome Measures

Progression of liver disease in patients with HCV [Annual visits]
Exams and labs
Progression of liver disease in patients with HBV [Annual visits]
exam and labs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

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

Be greater than or equal to 18 years old
HBV-infected and/or HCV-infected, or was HCV-infected and successfully treated
Willing to undergo genetic testing
Willingness to allow study staff to review your medical records between research visits
Willing to have samples stored for future research
Must have an identifiable primary care physician
Willing to undergo HIV testing
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:

Unable to comply with research study visits
Poor venous access
Have any condition that the investigator considers a contraindication to study participation.
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.