Clinical trial NCT05988879: Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients
Official title: A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AIDS
Hepatitis B
Keywords: HIV/HBV co-infection
Functional cure
Interferon
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.

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

Detailed 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.

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.

Primary outcomes:
measure: Hepatitis B surface antigen seroclearance
timeFrame: 48 weeks
Secondary outcomes:
measure: Hepatitis B surface antigen seroconversion
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital, Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Guangzhou Eighth People's Hospital
name: Linghua Li, PhD
role: STUDY_CHAIR
References: