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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01350648
Recruitment Status : Recruiting
First Posted : May 10, 2011
Last Update Posted : July 30, 2020
Washington D.C. Veterans Affairs Medical Center
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:


- 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 2000 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 : August 23, 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Progression of liver disease in patients with HCV [ Time Frame: Annual visits ]
    Exams and labs

  2. Progression of liver disease in patients with HBV [ Time Frame: Annual visits ]
    exam and labs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01350648

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Contact: Mary McLaughlin, R.N. (301) 435-8001
Contact: Colleen M Hadigan, M.D. (301) 594-5754

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Washington D.C. Veterans Affairs Medical Center
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Principal Investigator: Colleen M Hadigan, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institutes of Health Clinical Center (CC) Identifier: NCT01350648    
Other Study ID Numbers: 110152
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: June 30, 2020
Keywords provided by National Institutes of Health Clinical Center (CC):
Viral Hepatitis
Acquired Immunodeficiency Syndrome (AIDS)
Hepatocellular Carcinoma
HIV-HCV Co-Infection
Liver Neoplasms
Additional relevant MeSH terms:
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Communicable Diseases
Hepatitis A
Hepatitis C
HIV Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Parasitic Diseases