NCT05988879Recruiting
Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients
A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China
Source: ClinicalTrials.gov · Last updated 14 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 3 Aug 2023
- Start date
- 2 Aug 2023
- Primary completion date
- 2 Aug 2026
- Lead sponsor
- Guangzhou 8th People's Hospital
- Diseases
- Hepatitis B, HIV
- NCT number
- NCT05988879
What you commit to
- Study type: Observational
- Planned participants: 60
- From 2 Aug 2023 to the primary completion date, 2 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Excessive alcohol (average daily alcohol intake \>40g for men, \>20g for women) or drug users.
Other illness
- 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.
Other
- Participated in other interventional trials within the last three months, or other situations deemed inappropriate for inclusion by researchers.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangzhou Eighth People's Hospital, Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.