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Effect of combined antiretroviral therapy and interferon on hepatitis B surface antigen clearance in HIV/HBV co-infected patients: An observational, real-world study.

Effect of combined antiretroviral therapy and interferon on hepatitis B surface antigen clearance in HIV/HBV co-infected patients: An observational, real-world study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096548
Enrollment
Unknown
Registered
2025-01-26
Start date
2024-11-11
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/HBV co-infection

Interventions

ART combined with interferon group:None

Sponsors

Guangzhou Eighth Peoples Hospital Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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 200 cells/µL and HIV RNA<20 copies/ml.

Exclusion criteria

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. 9.ALT less than 10 times the upper limit of normal, total bilirubin less than 2 times the upper limit of normal; neutrophil count > 1.5 × 10^9/L, platelet count > 80 × 10^9/L (for the ART combined with interferon group only). 10.Non-invasive liver fibrosis markers, such as APRI 60 mL/min/1.73 m². (for the ART combined with interferon group only).

Design outcomes

Primary

MeasureTime frame
Hepatitis B surface antigen seroclearance;

Countries

China

Contacts

Public ContactLi Linghua

Guangzhou Eighth Peoples Hospital Guangzhou Medical University

llhelia@126.com+86 20 8371 0825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026