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NCT Number: NCT05988879

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

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

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Key information

About this study

This is a prospective, non-randomized, clinical observational cohort study. The subjects are the advantageous population for functional cure of hepatitis B in HIV/HBV co-infected patients . Depending on whether interferon therapy is used in the real world , the patients are divided into two groups: the ART combined with interferon group and the ART alone group, with 30 cases in each group. Hepatitis B surface antigen seroclearance rate and seroconversion rate will be observed during the study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Peginterferon alfa-2b injection

Drug

The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.

Primary outcomes

  1. Hepatitis B surface antigen seroclearance

    Time frame: 48 weeks

    Hepatitis B surface antigen quantification less than 0.05 IU/mL.

Secondary outcomes

  1. Hepatitis B surface antigen seroconversion

    Time frame: 48 weeks

    Clearance of surface antigen concurrently accompanied by the production of surface antibodies

Study contacts

Contact information is provided by the study sponsor or research team.

Linghua Li, PhD

CONTACT

[email protected]

+862083710825

Yaozu He, Master

CONTACT

[email protected]

+862083710825

Sponsors and collaborators

Lead sponsor

Guangzhou 8th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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