Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients
Recruiting · NCT05988879 · Observational (researchers observe without assigning treatment) · Lead sponsor: Guangzhou 8th People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Peginterferon alfa-2b Injection
What this trial is about
Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- Guangzhou Eighth People's Hospital, Guangzhou Medical University - Guangzhou, Guangdong, China
- Guangzhou Eighth People's Hospital, Guangzhou Medical University - Guangzhou, Guangdong, China