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Protocol Details

Observational Study of Hepatitis B Virus (HBV) in Patients Coinfected with Human Immunodeficiency Virus (HIV)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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

Special Instructions

Currently Not Provided

Keywords

Cirrhosis;
Toxicity;
Outcomes;
Hepatitis B Virus;
HIV

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)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

- 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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Eligibility

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.


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Citations:

Sorrell MF, Belongia EA, Costa J, Gareen IF, Grem JL, Inadomi JM, Kern ER, McHugh JA, Petersen GM, Rein MF, Strader DB, Trotter HT. National Institutes of Health Consensus Development Conference Statement: management of hepatitis B. Ann Intern Med. 2009 Jan 20;150(2):104-10. Epub 2009 Jan 5.

Benhamou Y. Hepatitis B in the HIV-coinfected patient. J Acquir Immune Defic Syndr. 2007 Jul 1;45 Suppl 2:S57-65; discussion S66-7.

Soriano V, Puoti M, Peters M, Benhamou Y, Sulkowski M, Zoulim F, Mauss S, Rockstroh J. Care of HIV patients with chronic hepatitis B: updated recommendations from the HIV-Hepatitis B Virus International Panel. AIDS. 2008 Jul 31;22(12):1399-410. doi: 10.1097/QAD.0b013e3282f8b46f.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Marc G. Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 10N248D
10 CENTER DR
BETHESDA MD 20814
(301) 402-5115
mg228m@nih.gov

Amy (Wen-Chun) Huang
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 4-5722
10 Center Drive
Bethesda, Maryland 20892
(301) 451-6983
wen-chun.huang@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

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