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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Washington D.C. Veterans Affairs Medical Center
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01350648
First received: May 7, 2011
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

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
Hepatitis
HIV
Liver Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 2000
Study Start Date: May 2011
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 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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 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:

- 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:

  1. Unable to comply with research study visits
  2. 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350648

Contacts
Contact: Colleen Kotb, R.N. (301) 594-1664 kotbch@mail.nih.gov
Contact: Shyamasundaran Kottilil, M.D. (301) 435-0936 skottilil@mail.nih.gov

Locations
United States, District of Columbia
VA Medical Center, Washington D.C. Recruiting
Washington, District of Columbia, United States, 20422
Family Medical and Counseling Services Recruiting
Washington, DC, District of Columbia, United States, 20020
Unity Health Care, Inc./Walker Jones Recruiting
Washington, DC, District of Columbia, United States, 20002
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Washington D.C. Veterans Affairs Medical Center
Investigators
Principal Investigator: Shyamasundaran Kottilil, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01350648     History of Changes
Other Study ID Numbers: 110152, 11-CC-0152
Study First Received: May 7, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Viral Hepatitis
Prospective Cohort
Hepatocellular Carcinoma
HIV-HCV Co-Infection
HIV-HBV Co-Infection
Hepatitis B
Hepatitis C
Hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis, Viral, Human
HIV Infections
Acquired Immunodeficiency Syndrome
Liver Diseases
Liver Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on July 26, 2014