Status:
RECRUITING
Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients
Lead Sponsor:
Guangzhou 8th People's Hospital
Conditions:
AIDS
Hepatitis B
Eligibility:
All Genders
18-65 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 2 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05988879
Start Date
August 2 2023
End Date
August 2 2028
Last Update
August 14 2023
Active Locations (1)
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1
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China, 510060