NCT05988879

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
27mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Aug 2023Aug 2028

Study Start

First participant enrolled

August 2, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2028

Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

August 3, 2023

Last Update Submit

August 10, 2023

Conditions

AIDSHepatitis B

Keywords

HIV/HBV co-infectionFunctional cureInterferon

Outcome Measures

Primary Outcomes (1)

  • Hepatitis B surface antigen seroclearance

    Hepatitis B surface antigen quantification less than 0.05 IU/mL.

    48 weeks

Secondary Outcomes (1)

  • Hepatitis B surface antigen seroconversion

    48 weeks

Study Arms (2)

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.

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.

Interventions

Peginterferon alfa-2b InjectionDRUG

The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.

ART combined with interferon group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

During the study, the blood sample of patients should be preserved to detect the HIV RNA load , HBV DNA load and ; other co-infected microbes and drug toxicity.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHepatitis B

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Linghua Li, PhD

    Guangzhou Eighth People's Hospital

    STUDY CHAIR

Central Study Contacts

Linghua Li, PhD

CONTACT

+862083710825llheliza@126.com

Yaozu He, Master

CONTACT

+862083710825hyzdyl99@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

August 2, 2023

Primary Completion (Estimated)

August 2, 2026

Study Completion (Estimated)

August 2, 2028

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)