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 : February 1, 2018
- 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.
- 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.
- People at least 18 years of age who have hepatitis B or hepatitis C and have a regular doctor for their medical care.
- 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 or disease|
|Hepatitis HIV Liver Cancer|
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 :||Observational|
|Estimated Enrollment :||2000 participants|
|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|
|Study Start Date :||May 11, 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350648
|Contact: Rachel E Silk, R.N.||(202) firstname.lastname@example.org|
|Contact: Colleen M Hadigan, M.D.||(301) email@example.com|
|United States, District of Columbia|
|Unity Health Care, Inc./Walker Jones||Recruiting|
|Washington, District of Columbia, United States, 20002|
|Family Medical and Counseling Services||Recruiting|
|Washington, District of Columbia, United States, 20020|
|VA Medical Center, Washington D.C.||Recruiting|
|Washington, District of Columbia, United States, 20422|
|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 firstname.lastname@example.org|
|Principal Investigator:||Colleen M Hadigan, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|