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

GZ8H-202316253

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

2023-08-02

2026-08-02

2028-08-02

Recruiting

60

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'During the study, the blood sample of patients should be preserved to detect the HIV RNA load , HBV DNA load and ; other co-infected microbes and drug toxicity.'}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-08-14