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

NCT01350648 | Completed

• 2 other identifiers: 11015211-CC-0152
• Study Type: observational
• Target: 569
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Progression of liver disease in patients with HCV

  Exams and labs

  Annual visits

• Progression of liver disease in patients with HBV

  exam and labs

  Annual visits

Study Arms (6)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• To be eligible for participation on this protocol, a participant must satisfy all of the following conditions:
• Be greater than or equal to 18 years old
• HBV-infected and/or HCV-infected, or was HCV-infected and successfully treated
• Willing to undergo genetic testing
• Willingness to allow study staff to review your medical records between research visits
• Willing to have samples stored for future research
• Must have an identifiable primary care physician
• Willing to undergo HIV testing
• 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.

You may not qualify if:

• A participant will be ineligible to participate on this study if any of the following criteria are met:
• Unable to comply with research study visits
• Poor venous access
• Have any condition that the investigator considers a contraindication to study participation.
• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• Washington D.C. Veterans Affairs Medical Center: collaborator

Study Sites (2)

VA Medical Center, Washington D.C.

Washington D.C., District of Columbia, 20422, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (5)

• Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2. doi: 10.1002/hep.23190. No abstract available.

  PMID: 19714720 BACKGROUND

• 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. doi: 10.1046/j.1365-2893.2003.00487.x.

  PMID: 14996343 BACKGROUND

• Alter MJ. Epidemiology of viral hepatitis and HIV co-infection. J Hepatol. 2006;44(1 Suppl):S6-9. doi: 10.1016/j.jhep.2005.11.004. Epub 2005 Nov 21.

  PMID: 16352363 BACKGROUND

• Balmaceda JB, Aepfelbacher J, Belliveau O, Chaudhury CS, Chairez C, McLaughlin M, Silk R, Gross C, Kattakuzhy S, Rosenthal E, Kottilil S, Kleiner DE, Hadigan C. Long-term changes in hepatic fibrosis following hepatitis C viral clearance in patients with and without HIV. Antivir Ther. 2019;24(4):451-457. doi: 10.3851/IMP3327.

  PMID: 31359874 DERIVED

• Chaudhury CS, Mee T, Chairez C, McLaughlin M, Silk R, Gross C, Kattakuzhy S, Rosenthal E, Kottilil S, Stanley TL, Hadigan C. Testosterone in Men With Chronic Hepatitis C Infection and After Hepatitis C Viral Clearance. Clin Infect Dis. 2019 Aug 1;69(4):571-576. doi: 10.1093/cid/ciy965.

  PMID: 30715229 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hepatitis B; Hepatitis C; Acquired Immunodeficiency Syndrome; Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Colleen M Hadigan, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2011
• First Posted: May 10, 2011
• Study Start: August 23, 2011
• Primary Completion: March 4, 2022
• Study Completion: March 17, 2022
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (2)