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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: 99

Referral Letter Required


Population Exclusion(s)



Viral Hepatitis;
Acquired Immunodeficiency Syndrome (AIDS);
Hepatocellular Carcinoma;
HIV-HCV Co-Infection;
Liver Neoplasms;
Natural History

Recruitment Keyword(s)



Hepatitis B;
Hepatitis C;
HIV-HCV Co-Infection

Investigational Drug(s)


Investigational Device(s)




Supporting Site

NIH Clinical CenterWashington DC Veterans Affairs Medical Center


- 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.

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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.


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.

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Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2.

Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat. 2004 Mar;11(2):97-107.

Alter MJ. Epidemiology of viral hepatitis and HIV co-infection. J Hepatol. 2006;44(1 Suppl):S6-9. Epub 2005 Nov 21.

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Principal Investigator

Referral Contact

For more information:

Colleen M. Hadigan, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CRC BG RM 6-2551
(301) 594-5754

Mary McLaughlin, R.N.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 8C404
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8001

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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