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HivCOMMITNCT03645044

Towards a Functional Cure for HBV - The COMMIT Cohort Study

An observational study of Hiv and HBV Coinfection, run by University of Melbourne at 3 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hiv, HBV Coinfection
How many people
102 participants
Where
3 sitesin 3 countries
Study dates
24 May 2018to Jul 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Male or female, aged 18 years and older
  • HIV antibody positive
  • Chronically-infected with HBV, as defined by:
  • 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
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

India1 site

  • YRGCare

    Chennai

Other trials in India

Malaysia1 site

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

    Kuala Lumpur

Other trials in Malaysia

Thailand1 site

  • HIV-NAT/Thai Red Cross AIDS Research Centre

    Bangkok

Other trials in Thailand

About this study

Official title: Towards a Functional Cure for HBV: Exploiting Lessons From HIV-HBV Co-infection: The COMMIT Cohort Study

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

Read the detailed description
  1. Aims and Objectives. Effective antiviral treatments of HBV are available, but treatment is lifelong in most so comes at considerable cost and with some toxicity. An effective therapeutic strategy to achieve a cure for HBV remains an unmet need. This project examines the key steps to HBV cure in the setting of HIV-HBV co-infection. Seroconversion is key to the cure. Seroconversion is the process where detectable antibody (specific protective protein produced by the immune system) against virus proteins (antigens) are developed in the blood. This proposed Asian HIV-HBV co-infection cohort (where treatment initiation is later and hence at lower cluster of differentiation 4 (CD4) counts) will provide a unique opportunity to test our hypothesis that following initiation of antiviral therapy, HB surface and "e" antigen loss is more frequent (i) early in treatment and (ii) with lower CD4 cell counts, and that predictors of losing HB surface and 'e" antigen (Ag) and gaining antibody (Ab) against them are directly associated with B-cell functions.
  2. Key Questions. Primary objective: to determine the rates \& clinical determinants of HBsAg and HBeAg loss and seroconversion in HIV-HBV co-infected patients commencing HBV-active antiretroviral (ART). We will test the hypotheses that: (i) seroconversion occurs predominantly in the early phase of treatment (≤12 months) with HBV active ART and (ii) seroconversion is more frequent in HIV-HBV co-infected individuals commencing treatment with lower CD4+ T cell counts (≤100 cells/mm3) compared to those with higher counts (>100 cells/mm3).

Secondary objectives: (i) identify predictive biomarkers of HBsAg loss/seroconversion and (ii) examine predictors of HBeAg loss/seroconversion in this setting

  1. Research Design. This is a large prospective, observational cohort study of treatment-naïve HIV-HBV co-infected patients (n=150). Clinical sites are - (1) HIV-Netherland-Australia-Thailand (HIV-NAT)/Thai Red Cross AIDS Research Centre, Bangkok, Thailand; (2) Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE), Chennai, India; and (3) Clinical Investigation Centre (CIC), University of Malaya, Infectious Diseases Directorate, Kuala Lumpur, Malaysia. Participants will be followed for 2 years, with study visits at baseline (study entry/initiation of treatment), months 3, 6, 12, 18, and 24 of follow-up. Clinical and laboratory information/data and blood samples will be collected at study visits.
Conditions
Hiv, HBV Coinfection
Keywords
HBV sAg loss/seroconversion, HBV "e" antigen (eAg) loss/seroconversion, antiretroviral therapy
Medical subject headings
Acquired Immunodeficiency Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HBsAg loss/seroconversion on ART

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

    Measured: 24 months

Secondary outcomes (6)

  1. HBeAg loss/seroconversion on ART

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

    Measured: 24 months

  2. HBsAg epitope profiles

    HBsAg epitope profiles at study entry and after 2 years of antiviral therapy in HBsAg responders and non-responders

    Measured: 24 months

  3. Differential B cell gene expression

    Differential B cell gene expression (genetic testing) in HBsAg responders and non-responders after 2 years of antiviral therapy

    Measured: 24 months

  4. B-cell activating factor (BAFF) levels

    Levels of BAFF in plasma at study entry and after 2 years of antiviral therapy in HBsAg responders and non-responders

    Measured: 24 months

  5. HBeAg and HBsAg specific memory B cells

    Proportion of HBeAg and HBsAg specific memory B cells at study entry and after 2 years of antiviral therapy

    Measured: 24 months

  6. B cell subtypes

    Percentage of B cell subtypes at study entry and after 2 years of antiviral therapy

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2018
  2. Study start24 May 2018
  3. Primary completion29 Apr 2022
  4. Study completionJul 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03645044
Sponsor's protocol ID
COMMIT study (NMHRC 1123988)
Acronym
COMMIT
Status last verified
Jul 2025
First submitted
22 Aug 2018
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hiv and HBV Coinfection, run by University of Melbourne at 3 sites in 3 countries.

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 9 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India, Malaysia, Thailand. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HBsAg loss/seroconversion on ART (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03645044.

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 17 Jul 2025.

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