Achieving a functional cure for hepatitis B in patients with HIV and hepatitis B co-infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study evaluates the effectiveness of combining antiretroviral therapy (ART) with interferon therapy to achieve a functional cure of hepatitis B in patients co-infected with HIV and hepatitis B. Participants will be divided into two groups: one receiving ART combined with interferon and the other receiving ART alone. The study will monitor the rates of hepatitis B surface antigen seroclearance and seroconversion over the study period. The goal is to determine if the addition of interferon enhances treatment outcomes for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-65 years old, gender unrestricted.
2. Meeting the People's Republic of China Health Industry Standard (WS293-2008) - "AIDS and HIV Infection Diagnostic Criteria", confirmed as HIV-1 infected.
3. HBsAg positive for more than 6 months.
4. At least 1 year of ART treatment prior to screening, and currently undergoing ART treatment with HBsAg \<1000IU/mL, HBeAg negative, HBV DNA \<100IU/ml, CD4+T lymphocyte count \>200 cells/μL and HIV-RNA\<20 copies/ml.

Exclusion Criteria:

1. Pregnant, nursing, planning pregnancy, or with severe mental disorders or uncontrolled epilepsy.
2. Co-infected with Hepatitis A, C, D, or E viruses.
3. With other chronic liver diseases like autoimmune hepatitis, drug-induced hepatitis, alcoholic hepatitis, genetic metabolic liver diseases, or moderate to severe fatty liver.
4. With autoimmune diseases like rheumatoid arthritis, psoriasis, or lupus.
5. Post organ transplant, planning organ transplant, diagnosed or suspected of liver cancer or other malignant tumors, or undergoing immunosuppressive treatment.
6. With severe diseases of heart, lungs, kidneys, brain, retinal disorders, or uncontrolled hypertension or diabetes.
7. Excessive alcohol (average daily alcohol intake \>40g for men, \>20g for women) or drug users.
8. Participated in other interventional trials within the last three months, or other situations deemed inappropriate for inclusion by researchers.

Where it's running

• Guangzhou Eighth People's Hospital, Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Linghua Li, PhD
• Email: llheliza@126.com
• Phone: +862083710825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.