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)
Facility
City
Region
Status
YRGCare
Chennai
India
Clinical Investigation Centre (CIC), University of Malaya, Infectious Diseases Directorate
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.