Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peginterferon alfa-2b Injection.
- Who it may be relevant to
- Registry conditions: AIDS, Hepatitis B. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China
Overview
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
- Drug Peginterferon alfa-2b Injection
The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.
Primary outcome measures
- Hepatitis B surface antigen seroclearance [Time frame: 48 weeks]
Secondary outcome measures (1)
- Hepatitis B surface antigen seroconversion [Time frame: 48 weeks]
Eligibility criteria
Inclusion criteria
- Age 18-65 years old, gender unrestricted.
- Meeting the People's Republic of China Health Industry Standard (WS293-2008) - "AIDS and HIV Infection Diagnostic Criteria", confirmed as HIV-1 infected.
- HBsAg positive for more than 6 months.
- 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
- Pregnant, nursing, planning pregnancy, or with severe mental disorders or uncontrolled epilepsy.
- Co-infected with Hepatitis A, C, D, or E viruses.
- With other chronic liver diseases like autoimmune hepatitis, drug-induced hepatitis, alcoholic hepatitis, genetic metabolic liver diseases, or moderate to severe fatty liver.
- With autoimmune diseases like rheumatoid arthritis, psoriasis, or lupus.
- Post organ transplant, planning organ transplant, diagnosed or suspected of liver cancer or other malignant tumors, or undergoing immunosuppressive treatment.
- With severe diseases of heart, lungs, kidneys, brain, retinal disorders, or uncontrolled hypertension or diabetes.
- Excessive alcohol (average daily alcohol intake >40g for men, >20g for women) or drug users.
- Participated in other interventional trials within the last three months, or other situations deemed inappropriate for inclusion by researchers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Guangzhou Eighth People's Hospital, Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT05988879 · GZ8H-202316253