NCT05988879 Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients
| NCT ID | NCT05988879 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou 8th People's Hospital |
| Condition | AIDS |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-08-02 |
| Primary Completion | 2026-08-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2023-08-02 with a primary completion date of 2026-08-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients
Eligibility 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 \<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.
Contact & Investigator
Linghua Li, PhD
STUDY CHAIR
Guangzhou Eighth People's Hospital
Frequently Asked Questions
Who can join the NCT05988879 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying AIDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05988879 currently recruiting?
Yes, NCT05988879 is actively recruiting participants. Contact the research team at llheliza@126.com for enrollment information.
Where is the NCT05988879 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05988879 clinical trial?
NCT05988879 is sponsored by Guangzhou 8th People's Hospital. The principal investigator is Linghua Li, PhD at Guangzhou Eighth People's Hospital. The trial plans to enroll 60 participants.