AIDSNCT05988879
Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients
An observational study of AIDS and Hepatitis B, run by Guangzhou 8th People's Hospital at 1 site in China.
Trial summary
Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS, Hepatitis B
- What is being tested?
- Peginterferon alfa-2b Injection
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2023to 2 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510060
Linghua Li, PhD, +862083710825, llheliza@126.com
Yaozu He, Master, +862083710825, hyzdyl99@163.com
About this study
Official title: A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China
Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients
Read the 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.
- Conditions
- AIDS, Hepatitis B
- Being tested
- Peginterferon alfa-2b Injection
- Keywords
- HIV/HBV co-infection, Functional cure, Interferon
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2b InjectionDrug
The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.
| Study group | Role | What they receive |
|---|---|---|
| ART combined with interferon group | The treatment protocol is ART combined with pegylated interferon α-2b injection. The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week. Follow-up times are at baseline, and during treatment at weeks 4, 8, 12, 24, 36, 48, 60, and 72. Receives: Drug: Peginterferon alfa-2b Injection | |
| ART group | Continuously using ART treatment, without the use of interferon. Follow-up times are at baseline, and during treatment at weeks 12, 24, 36, 48, 60, and 72. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis B surface antigen seroclearance
Hepatitis B surface antigen quantification less than 0.05 IU/mL.
Measured: 48 weeks
Secondary outcomes (1)
Hepatitis B surface antigen seroconversion
Clearance of surface antigen concurrently accompanied by the production of surface antibodies
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Aug 2023
- Primary completion2 Aug 2026 (estimated)
- Study completion2 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou 8th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linghua LI, Guangzhou 8th People's Hospital
- Investigators
- Linghua Li, PhD, Study chair, Guangzhou Eighth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988879
- Sponsor's protocol ID
- GZ8H-202316253
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China
- ClinicalTrials.gov ID
- NCT05988879
- Acronym / sponsor ID
- GZ8H-202316253
- Conditions
- AIDS, Hepatitis B
- Keywords
- HIV/HBV co-infection, Functional cure, Interferon
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou 8th People's HospitalUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 2 Aug 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART combined with interferon group | – | Drug: Peginterferon alfa-2b InjectionThe treatment protocol is ART combined with pegylated interferon α-2b injection. The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week. Follow-up times are at baseline, and during treatment at weeks 4, 8, 12, 24, 36, 48, 60, and 72. |
| ART group | – | –Continuously using ART treatment, without the use of interferon. Follow-up times are at baseline, and during treatment at weeks 12, 24, 36, 48, 60, and 72. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon alfa-2b InjectionThe pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week. | Drug | ART combined with interferon group |
Primary outcome
Hepatitis B surface antigen seroclearance
Time frame: 48 weeks
Hepatitis B surface antigen quantification less than 0.05 IU/mL.
1 secondary outcome
Hepatitis B surface antigen seroconversion
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linghua Li, PhD study chair
Guangzhou Eighth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS and Hepatitis B, run by Guangzhou 8th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linghua Li, PhD (+862083710825, llheliza@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatitis B surface antigen seroclearance (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.