Achieving a functional cure for hepatitis B in patients with HIV and hepatitis B co-infection

A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China

This study is testing if adding interferon to standard HIV treatment can help people who have both HIV and hepatitis B clear the virus from their system.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Guangzhou 8th People's Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05988879 on ClinicalTrials.gov

What this trial studies

This observational cohort study evaluates the effectiveness of combining antiretroviral therapy (ART) with interferon therapy to achieve a functional cure of hepatitis B in patients co-infected with HIV and hepatitis B. Participants will be divided into two groups: one receiving ART combined with interferon and the other receiving ART alone. The study will monitor the rates of hepatitis B surface antigen seroclearance and seroconversion over the study period. The goal is to determine if the addition of interferon enhances treatment outcomes for this patient population.

Who should consider this trial

Good fit: Ideal candidates are HIV-1 infected individuals aged 18-65 who have been on ART for at least one year and have specific viral load and CD4+ T lymphocyte count criteria.

Not a fit: Patients who are pregnant, have severe mental disorders, or are co-infected with other hepatitis viruses or chronic liver diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to a functional cure for hepatitis B in co-infected patients, significantly improving their health outcomes.

How similar studies have performed: While this approach is being explored, the combination of ART and interferon for this specific co-infection has not been extensively tested, making this a novel investigation.

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.

Where this trial is running

Guangzhou, Guangdong

• Guangzhou Eighth People's Hospital, Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Linghua Li, PhD

Conditions AIDS; Hepatitis B; HIV/HBV co-infection; Functional cure; Interferon