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RECRUITINGOBSERVATIONAL

Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients

A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Peginterferon alfa-2b Injection

The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.

Locations (1)

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