HIV/HBV Co-infection
Conditions
Interventions
Non-IFN group:ART containing TFV
IFN group:On the basis of TFV-ART, adding Peg-IFN treatment.
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Part I: 1. Age >=18 years old, male or female; 2. All enrolled subjects were HIV-positive patients and met the diagnostic criteria for HBV infection, according to the Expert Consensus on Diagnosis and Treatment of HIV with HBV and HCV Infection in China (2024 edition); Part Two: 1.Age 18 to 65 years old. 2.Under conditions of good compliance, the duration of ART treatment containing TFV is =48 weeks. 3.HIV RNA < 50 copies/mL and CD4+ T-cell count = 450 cells/mm³, HBV DNA < 100 IU/mL at the time of screening. 4.Voluntarily participate in this clinical trial and be able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Part I: 1. Patients with incomplete clinical data or missing key analysis indicators; Part Two: 1.Combination of HIV opportunistic infections. 2.Decompensated cirrhosis. 3.Patients with concurrent infection of hepatotropic viruses such as HCV. 4.Retinal lesions or clinically significant ophthalmic diseases. 5.Alcoholics or drug addicts. 6.Before treatment, neutrophil count 34 µmol/L. 7.Autoimmune liver disease, malignant tumors, and interferon contraindications (such as severe cardiopulmonary disease, renal insufficiency, uncontrolled asthma or diabetes, unstable thyroid or other severe endocrine disorders, uncontrolled epileptic seizures, severe mental illness, active pulmonary tuberculosis currently under treatment, psoriasis, etc.), pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg clearance rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg clearance rate;HBsAg change.;HBV DNA;HBeAg clearance rate;HBeAg seroconversion rate; | — |
Countries
China
Contacts
Public ContactJiang Taiyi
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed