Towards a Functional Cure for HBV - The COMMIT Cohort Study

NCT03645044 | Active Not Recruiting

• 1 other identifier: COMMIT study (NMHRC 1123988)
• Study Type: observational
• Target: 102
• Locations: 3 countries
• Sites: 3

Brief Summary

Hepatitis B virus (HBV) infection can be treated, but therapy is usually lifelong and has side effects, so a cure for HBV is a critical endpoint. This study examines the key steps to HBV cure in the setting of HIV-HBV co-infection, where rates of development of antibodies against HBV after starting HBV treatment are higher than in people with HBV alone starting treatment. In Asia both HBV and HIV are common so this provides a unique opportunity to study HBV. We will investigate how an effective immune response against the two main HBV proteins is developed. If we can understand how the immune response works against HBV, this could be used to develop new therapies towards a cure for HBV

Conditions

Hiv; HBV Coinfection

Keywords

HBV sAg loss/seroconversion; HBV "e" antigen (eAg) loss/seroconversion; antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• HBsAg loss/seroconversion on ART

  Frequency of HBsAg loss/seroconversion in early (first 12 months) compared to later stage

  24 months

Secondary Outcomes (6)

• HBeAg loss/seroconversion on ART

  24 months

• HBsAg epitope profiles

  24 months

• Differential B cell gene expression

  24 months

• B-cell activating factor (BAFF) levels

  24 months

• HBeAg and HBsAg specific memory B cells

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anti-retroviral treatment (ART) naïve (or within 7-10 days of ART start where immediate ART start (test and treat) is practice) HIV-HBV co-infected individuals about to commence ART, aged 18 years and older

You may qualify if:

• Male or female, aged 18 years and older
• HIV antibody positive
• Chronically-infected with HBV, as defined by:
• i. Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result (the 2nd HBsAg test may be taken at the baseline visit) ii. HBsAg positive with the absence of immunoglobulin M antibodies to HBV core at screening
• Current or ever hepatitis C virus (HCV) antibody negative
• Hepatitis D virus (HDV) negative
• ART naïve or within 7-10 days of ART start at sites where immediate ART start (test and treat) is practice
• Provide signed and dated informed consent form.
• Willing to comply with all study procedures and be available for the duration of the study.

You may not qualify if:

• Hepatitis C virus (HCV) antibody positive
• Hepatitis delta antibody positive
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Sponsors & Collaborators

• University of Melbourne: lead
• National Health and Medical Research Council, Australia: collaborator
• The University of Western Australia: collaborator
• University of Adelaide: collaborator
• The HIV Netherlands Australia Thailand Research Collaboration: collaborator
• University of Malaya: collaborator
• YR Gaitonde Centre for AIDS Research and Education: collaborator
• Melbourne Health: collaborator

Study Sites (3)

YRGCare

Chennai, India

Location

Clinical Investigation Centre (CIC), University of Malaya, Infectious Diseases Directorate

Kuala Lumpur, Malaysia

Location

HIV-NAT/Thai Red Cross AIDS Research Centre

Bangkok, Thailand

Location

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cells (PBMCs) and plasma

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Joe Sasadeusz, MBBS, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious Diseases physician

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: May 24, 2018
• Primary Completion: April 29, 2022
• Study Completion: July 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); IN (1); TH (1)