Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection
Hepatitis - HIV - Liver Cancer
Conditions: official terms
HIV Infections - Hepatitis - Hepatitis A - Hepatitis B - Hepatitis C - Liver Diseases
Conditions: Keywords
Viral Hepatitis, Prospective Cohort, Hepatocellular Carcinoma, HIV-HCV Co-Infection, HIV-HBV Co-Infection, Hepatitis B, Hepatitis C, Hepatitis
Study Type
Study Phase
Study Design
Time Perspective: Prospective
Overall Status

- 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.


- 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.


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


- 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.
Detailed Description
Chronic hepatitis is a major health problem with hepatitis B virus (HBV) affecting upwards of 350 million people worldwide and over one million in the United States, while hepatitis C virus (HCV) infects as many as 70-130 million people worldwide, and approximately 4.1 million (1.6% of the US population) in the United States. HBV and HCV are both transmitted sexually, perinatally and percutaneously, although each virus has differing infectivity rates depending on the mode of transmission. The immunosuppressed population, especially those with HIV infection, remains at particular risk given common routes of transmission. 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.

The prevalence rates of HIV in Washington DC are likely 3%. HIV-hepatitis coinfection is problematic in that HIV patients are currently living longer on highly active antiretroviral therapy (HAART) but often die of complications from liver disease, including HCC. Those who are coinfected with HBV and/or HCV progress more rapidly to cirrhosis and hepatic failure. Treatment for chronic HBV and HCV is limited, even inadequate, especially in those with HIV and HCV coinfection. Further research on the epidemiology, optimal screening and new therapeutic approaches in HCC 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. There are few longitudinal research cohorts of participants with viral hepatitis and HIV coinfection, especially at integrated medical care centers. The study, including a participant questionnaire for HCV infected participants only and phlebotomy, will be administered on-site at clinical facilities in the District of Columbia and at the National Institutes of Health. 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.

The integrated clinics will provide an optimal environment for the adherence and engagement of medical care and education in decreasing transmission risks of infection. The study will establish a blood and specimen repository for participants and include a research database that will be used prospectively to test future hypotheses.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both

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

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.


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.

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.
Family Medical and Counseling Services
Washington, DC, District of Columbia, United States
Status: Recruiting
Unity Health Care, Inc./Walker Jones
Washington, DC, District of Columbia, United States
Status: Recruiting
VA Medical Center, Washington D.C.
Washington, District of Columbia, United States
Status: Recruiting
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Status: Recruiting
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) - 800-411-1222 - prpl@mail.cc.nih.gov
Start Date
May 2011
National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page