RecruitingNot Applicable

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

China60 participantsStarted 2023-08-02

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Hepatitis B surface antigen seroclearance

Timeframe: 48 weeks

NCT IDNCT05988879

SponsorGuangzhou 8th People's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-02

Linghua Li, PhD

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.