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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988879
• Other study ID #: GZ8H-202316253
• Status: Recruiting
• Start date: August 2, 2023
• Est. completion date: August 2, 2028

Study information

• Verified date: August 2023
• Source: Guangzhou 8th People's Hospital
• Contact: Linghua Li, PhD
• Phone: +862083710825
• Email: llheliza[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2, 2028
• Est. primary completion date: August 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• AIDS
• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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

Locations

Country	Name	City	State
China	Guangzhou Eighth People's Hospital, Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou 8th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatitis B surface antigen seroclearance	Hepatitis B surface antigen quantification less than 0.05 IU/mL.	48 weeks
Secondary	Hepatitis B surface antigen seroconversion	Clearance of surface antigen concurrently accompanied by the production of surface antibodies	48 weeks