Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection
|First Received Date ICMJE||May 7, 2011|
|Last Updated Date||September 16, 2016|
|Start Date ICMJE||May 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01350648 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection|
|Official Title ICMJE||The Natural History of Liver Disease in a Cohort of Participants With Hepatitis B and/or Hepatitis C With or Without HIV Infection|
- 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.
- People at least 18 years of age who have hepatitis B or hepatitis C and have a regular doctor for their medical care.
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 with and without HIV with an emphasis on those living 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 for HCV infected participants only and phlebotomy, will be administered on-site at clinical facilities in the District of Columbia and at the National Institutes of Health. 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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||2000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be eligible for participation on this protocol, a participant must satisfy all of the following conditions:
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:
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.
|Ages||18 Years to 99 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01350648|
|Other Study ID Numbers ICMJE||110152, 11-CC-0152|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC)|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Washington D.C. Veterans Affairs Medical Center|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP