This study is NOT currently recruiting participants.
Number
15-DK-0079
Sponsoring Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Cirrhosis; Toxicity; Outcomes; Hepatitis B Virus; HIV; Natural History
Recruitment Keyword(s)
None
Condition(s)
Cirrhosis; HIV Infections; Hepatitis B; Chronic Hepatitis B e Antigen Positive; Chronic Hepatitis B e Antigen Negative
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Diabetes and Digestive and Kidney Diseases
- Chronic liver disease from coinfection with hepatitis B (HBV) or C is the second leading cause of death among people with human immunodeficiency virus (HIV). The course of HBV infection is more rapid in those with HIV. Guidelines suggest that most coinfected people be treated for both HIV and HBV using antiretroviral therapy (ART) combinations that include tenofovir (TDF). This is common in the U.S. But its effect on long-term HBV outcomes is unknown. Researchers want to study the effects of TDF-based therapy for chronic hepatitis B in people with HIV coinfection.
Objectives:
- To find the degree of liver injury in people with HIV-HBV coinfection. To study the role HIV treatment may have on HBV infection. To find ways to assess liver damage without a biopsy.
Eligibility:
- Adults 18 and older with HIV-HBV coinfection who are currently getting HIV treatment, preferably with a TDF-based regimen.
Design:
- Participants will be screened with medical history, physical exam, and blood and urine tests. They will complete questionnaires. They will need to undergo a liver biopsy.
- For biopsy, participants will have an ultrasound of their liver. They will get a sedative in an arm vein. The skin over the liver will be numbed. A needle will pass through the skin and remove a piece of liver tissue.
- Participants will be in the study for 4 years. They will visit NIH every 6 months. They will give blood at each visit.
- Participants who get pregnant will give extra blood samples and complete extra questionnaires while pregnant.
- Participants will have a liver biopsy after 4 years, unless they are pregnant.
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INCLUSION CRITERIA: -Male and female subjects to 18 years of age or older -Serologic evidence of HIV infection by HIV antibody positivity or history of positive HIV-RNA prior to screening -Serologic evidence of chronic hepatitis B infection by HBsAg positivity -Currently receiving any type of anti-retroviral therapy for HBV or HIV -Willingness to provide informed consent. EXCLUSION CRITERIA: -Estimated life expectancy of less than one year based on clinical judgment of the investigator -History of hepatic decompensation based on clinical or laboratory criteria -Hepatocellular carcinoma (HCC) -HCV RNA positive within 6 months prior to the baseline biopsy -History of solid organ or bone marrow transplantation -Pregnant women -Medical or social condition which, in the opinion of the study physician, would make the patient unsuitable for the study or interfere with or prevent follow-up per protocol -Unable or unwilling to return for follow-up visits -Contraindications to liver biopsy.
-Male and female subjects to 18 years of age or older
-Serologic evidence of HIV infection by HIV antibody positivity or history of positive HIV-RNA prior to screening
-Serologic evidence of chronic hepatitis B infection by HBsAg positivity
-Currently receiving any type of anti-retroviral therapy for HBV or HIV
-Willingness to provide informed consent.
EXCLUSION CRITERIA:
-Estimated life expectancy of less than one year based on clinical judgment of the investigator
-History of hepatic decompensation based on clinical or laboratory criteria
-Hepatocellular carcinoma (HCC)
-HCV RNA positive within 6 months prior to the baseline biopsy
-History of solid organ or bone marrow transplantation
-Pregnant women
-Medical or social condition which, in the opinion of the study physician, would make the patient unsuitable for the study or interfere with or prevent follow-up per protocol
-Unable or unwilling to return for follow-up visits
-Contraindications to liver biopsy.
Principal Investigator
Referral Contact
For more information: