Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection
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|ClinicalTrials.gov Identifier: NCT01350648|
Recruitment Status : Recruiting
First Posted : May 10, 2011
Last Update Posted : October 29, 2018
|First Submitted Date||May 7, 2011|
|First Posted Date||May 10, 2011|
|Last Update Posted Date||October 29, 2018|
|Study Start Date||May 11, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01350648 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection|
|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|
- 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 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||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||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.
|Original Estimated Enrollment||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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, Older Adult)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||110152
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC)|
|Study Sponsor||National Institutes of Health Clinical Center (CC)|
|Collaborators||Washington D.C. Veterans Affairs Medical Center|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 14, 2018|