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Clinical Trials in China / NCT05988879
Recruiting Observational

Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients

NCT05988879 · tracked via the Priya Life Science China tracker
Sponsor
Guangzhou 8th People's Hospital
Phase
Observational
Started
2023-08-02
Last updated
2023-08-14

Condition(s) studied

AIDSHepatitis B

Investigational drug(s) / intervention(s)

Peginterferon alfa-2b Injection

Peginterferon alfa-2b Injection: The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Guangzhou Eighth People's Hospital, Guangzhou Medical University Guangzhou Guangdong Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05988879 on ClinicalTrials.gov ↗ ← All trials in China