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

18 Years
Open (Enrolling)
Hepatitis, HIV, Liver Cancer

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Trial Information

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

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 living with and
without HIV 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 survey and
phlebotomy, will be administered on-site at clinical facilities in the District of Columbia.
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,
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

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.

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

3. Willing to undergo genetic testing

4. Willingness to allow study staff to review your medical records between research

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

- 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

- 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

- 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. Have any condition that the investigator considers a contraindication to study

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.

Type of Study:


Study Design:

Time Perspective: Prospective

Principal Investigator

Shyamasundaran Kottilil, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Allergy and Infectious Diseases (NIAID)


United States: Federal Government

Study ID:




Start Date:

May 2011

Completion Date:

Related Keywords:

  • Hepatitis
  • HIV
  • Liver Cancer
  • Viral Hepatitis
  • Prospective Cohort
  • Hepatocellular Carcinoma
  • HIV-HCV Co-Infection
  • HIV-HBV Co-Infection
  • Hepatitis B
  • Hepatitis C
  • Hepatitis
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Hepatitis C
  • Liver Diseases
  • Liver Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892
VA Medical Center, Washington D.C. Washington, District of Columbia  20422
Family Medical and Counseling Services Washington, DC, District of Columbia  20020
Unity Health Care, Inc./Walker Jones Washington, DC, District of Columbia  20002