NCT03645044Active, not recruiting
Towards a Functional Cure for HBV - The COMMIT Cohort Study
Towards a Functional Cure for HBV: Exploiting Lessons From HIV-HBV Co-infection: The COMMIT Cohort Study
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 102 (actual)
- First submitted
- 22 Aug 2018
- Start date
- 24 May 2018
- Primary completion date
- 29 Apr 2022
- Lead sponsor
- University of Melbourne
- Diseases
- HIV
- NCT number
- NCT03645044
What you commit to
- Study type: Observational
- Participants enrolled: 102
- From 24 May 2018 to the primary completion date, 29 Apr 2022
- 3 sites in 3 countries
- 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.
Other illness
- Hepatitis C virus (HCV) antibody positive
- Hepatitis delta antibody positive
Other
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Who the study is looking for
- 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
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| YRGCare Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Clinical Investigation Centre (CIC), University of Malaya, Infectious Diseases Directorate Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| HIV-NAT/Thai Red Cross AIDS Research Centre Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.