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

ConditionsAIDS Hepatitis B

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorGuangzhou 8th People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: ART combined with interferon group1 intervention

Group B: ART group0 interventions

Trial outcomes

Primary outcomes

Hepatitis B surface antigen seroclearance

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

Time frame

48 weeks

Secondary outcomes

Hepatitis B surface antigen seroconversion

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

Time frame

48 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou 8th People's Hospital

Lead sponsor

Source ClinicalTrials.gov

Apply now