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

Launched by GUANGZHOU 8TH PEOPLE'S HOSPITAL · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people who are living with both HIV and hepatitis B, aiming for what is called a "functional cure" for hepatitis B. The study will test a combination of antiretroviral therapy (ART), which helps manage HIV, along with a treatment called interferon. The goal is to see if this combination can effectively reduce or eliminate the hepatitis B virus in patients who have been living with it for a while.

To be eligible for this trial, participants need to be between 18 and 65 years old and must have a confirmed HIV-1 infection. They should have been diagnosed with hepatitis B for more than six months and have been on ART for at least a year. It’s important for participants to meet certain health criteria, such as having a low level of hepatitis B virus in their blood. Those who are pregnant, have other serious liver conditions, or specific health issues may not qualify. If you join the trial, you can expect regular check-ups and monitoring by healthcare professionals to ensure your safety and track the effectiveness of the treatment.

Gender

ALL

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.