Hepatitis BNCT01350648
Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection
An observational study of Hepatitis B and Hepatitis C, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatitis B, Hepatitis C, HIV-HCV Co-Infection
- How many people
- 569 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Aug 2011to 17 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NIH NIAID Outpatient Clinic 8 Participants, local Washington DC Primary Clinics, and formerly the Washington DC VA Clnic
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
VA Medical Center, Washington D.C.
Washington D.C., District of Columbia, 20422
About this study
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
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.
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Hepatitis B, Hepatitis C, Acquired Immunodeficiency Syndrome, Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of liver disease in patients with HCV
Exams and labs
Measured: Annual visits
Progression of liver disease in patients with HBV
exam and labs
Measured: Annual visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study start23 Aug 2011
- Primary completion4 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Washington D.C. Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Colleen M Hadigan, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350648
- Sponsor's protocol ID
- 110152
- Other IDs
- 11-CC-0152
- Status last verified
- Sep 2024
- First submitted
- 7 May 2011
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2. doi: 10.1002/hep.23190. No abstract available.
PubMed 19714720Lavanchy 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.
PubMed 14996343Alter 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.
PubMed 16352363Balmaceda 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.
PubMed 31359874Chaudhury 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.
PubMed 30715229
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01350648
- Acronym / sponsor ID
- 110152
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- Washington D.C. Veterans Affairs Medical Center
- Study start
- 23 Aug 2011 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NIH NIAID Outpatient Clinic 8 Participants, local Washington DC Primary Clinics, and formerly the Washington DC VA Clnic
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression of liver disease in patients with HCV
Time frame: Annual visits
Exams and labs
Progression of liver disease in patients with HBV
Time frame: Annual visits
exam and labs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 19714720Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2. doi: 10.1002/hep.23190. No abstract available.
- Background: PubMed 14996343Lavanchy 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.
- Background: PubMed 16352363Alter 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.
- Derived from this study: PubMed 31359874Balmaceda 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.
- Derived from this study: PubMed 30715229Chaudhury 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen M Hadigan, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis C, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of liver disease in patients with HCV (time frame: Annual visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01350648, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.