Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients
NCT ID: NCT05988879
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2023-08-02
2028-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ART combined with interferon group
The treatment protocol is ART combined with pegylated interferon α-2b injection. The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week. Follow-up times are at baseline, and during treatment at weeks 4, 8, 12, 24, 36, 48, 60, and 72.
Peginterferon alfa-2b Injection
The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.
ART group
Continuously using ART treatment, without the use of interferon. Follow-up times are at baseline, and during treatment at weeks 12, 24, 36, 48, 60, and 72.
No interventions assigned to this group
Interventions
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Peginterferon alfa-2b Injection
The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Guangzhou 8th People's Hospital
OTHER
Responsible Party
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Linghua LI
Chief physician
Principal Investigators
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Linghua Li, PhD
Role: STUDY_CHAIR
Guangzhou Eighth People's Hospital
Locations
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Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GZ8H-202316253
Identifier Type: -
Identifier Source: org_study_id
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