AIDS, Hepatitis B
Conditions
Keywords
HIV/HBV co-infection, Functional cure, Interferon
Brief summary
Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients
Detailed description
This is a prospective, non-randomized, clinical observational cohort study. The subjects are the advantageous population for functional cure of hepatitis B in HIV/HBV co-infected patients . Depending on whether interferon therapy is used in the real world , the patients are divided into two groups: the ART combined with interferon group and the ART alone group, with 30 cases in each group. Hepatitis B surface antigen seroclearance rate and seroconversion rate will be observed during the study period.
Interventions
The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.
Sponsors
Guangzhou 8th People's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis B surface antigen seroclearance | 48 weeks | Hepatitis B surface antigen quantification less than 0.05 IU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis B surface antigen seroconversion | 48 weeks | Clearance of surface antigen concurrently accompanied by the production of surface antibodies |
Countries
China
Contacts
Primary ContactLinghua Li, PhD
Backup ContactYaozu He, Master
Outcome results
None listed