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Clinical Trials in India / NCT03645044
Active, not recruiting Observational

Towards a Functional Cure for HBV - The COMMIT Cohort Study

NCT03645044 · tracked via the Priya Life Science India tracker
Sponsor
University of Melbourne
Phase
Observational
Started
2018-05-24
Last updated
2025-07-17

Condition(s) studied

HivHBV Coinfection

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • HBsAg loss/seroconversion on ART — 24 months
    Frequency of HBsAg loss/seroconversion in early (first 12 months) compared to later stage

Trial sites (3)

FacilityCityRegionStatus
YRGCare Chennai India
Clinical Investigation Centre (CIC), University of Malaya, Infectious Diseases Directorate Kuala Lumpur Malaysia
HIV-NAT/Thai Red Cross AIDS Research Centre Bangkok Thailand

Other trials for the same condition

Vicente Ferrer HIV Cohort Study Recruiting
Alcohol Reduction Among People With TB and HIV in India Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03645044 on ClinicalTrials.gov ↗ ← All trials in India