HBV-HIV Coinfection Research Network
2 other identifiers
observational
139
2 countries
8
Brief Summary
Despite effective ART that can suppress both HIV and HBV, HBV-related liver disease remains a significant co-morbidity in this population. Little is known about the histologic spectrum of liver disease, the significance of complete vs. incomplete HBV suppression, the utility of novel virologic and serum markers of disease severity, and the long-term renal and bone effects of TDF-based therapy. This proposal will address these important questions and impact the science and health of those coinfected with HBV-HIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2014
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedMay 16, 2023
May 1, 2023
5 years
August 12, 2013
May 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Liver disease severity
We will clinically, histologically, serologically, and virologically characterize a well-defined cohort of HBV-HIV patients in North America in a cross-sectional manner
4 years
Secondary Outcomes (1)
Outcome of viral suppression
4 years
Study Arms (1)
HBV-HIV coinfected subjects
HBV-HIV coinfected subjects seen at one of 7 participating centers.
Eligibility Criteria
HBV-HIV coinfection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of California
San Francisco, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
NIDDK
Bethesda, Maryland, United States
Mass General Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
UT Southwestern
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Toronto Hospital
Toronto, Ontario, Canada
Related Publications (6)
Lisker-Melman M, King WC, Ghany MG, Chung RT, Hinerman AS, Cloherty GA, Khalili M, Jain MK, Sulkowski M, Sterling RK. Human immunodeficiency virus coinfection differentially impacts hepatitis B virus viral markers based on hepatitis Be antigen status in patients with suppressed viremia. J Viral Hepat. 2023 Aug;30(8):700-709. doi: 10.1111/jvh.13857. Epub 2023 Jun 6.
PMID: 37278302DERIVEDLisker-Melman M, Wahed AS, Ghany MG, Chung RT, King WC, Kleiner DE, Bhan AK, Khalili M, Jain MK, Sulkowski M, Wong DK, Cloherty G, Sterling RK. HBV transcription and translation persist despite viral suppression in HBV-HIV co-infected patients on antiretroviral therapy. Hepatology. 2023 Feb 1;77(2):594-605. doi: 10.1002/hep.32634. Epub 2022 Jul 21.
PMID: 35770681DERIVEDSterling RK, King WC, Khalili M, Chung RT, Sulkowski M, Jain MK, Lisker-Melman M, Ghany MG, Wong DK, Hinerman AS, Bhan AK, Wahed AS, Kleiner DE; HBV-HIV Cohort Study of the Hepatitis B Research Network. A Prospective Study Evaluating Changes in Histology, Clinical and Virologic Outcomes in HBV-HIV Co-infected Adults in North America. Hepatology. 2021 Sep;74(3):1174-1189. doi: 10.1002/hep.31823. Epub 2021 Aug 25.
PMID: 33743541DERIVEDSterling RK, King WC, Khalili M, Kleiner DE, Hinerman AS, Sulkowski M, Chung RT, Jain MK, Lisker-Melman MA, Wong DK, Ghany MG; HBV-HIV Cohort Study of the Hepatitis B Research Network. Performance of Serum-Based Scores for Identification of Mild Hepatic Steatosis in HBV Mono-infected and HBV-HIV Co-infected Adults. Dig Dis Sci. 2022 Feb;67(2):676-688. doi: 10.1007/s10620-021-06860-3. Epub 2021 Feb 8.
PMID: 33559089DERIVEDKhalili M, King WC, Kleiner DE, Jain MK, Chung RT, Sulkowski M, Lisker-Melman M, Wong DK, Ghany M, Sanyal A, Sterling RK. Fatty Liver Disease in a Prospective North American Cohort of Adults With Human Immunodeficiency Virus and Hepatitis B Virus Coinfection. Clin Infect Dis. 2021 Nov 2;73(9):e3275-e3285. doi: 10.1093/cid/ciaa1303.
PMID: 32869840DERIVEDSterling RK, King WC, Wahed AS, Kleiner DE, Khalili M, Sulkowski M, Chung RT, Jain MK, Lisker-Melman M, Wong DK, Ghany MG; HIV-HBV Cohort Study of the Hepatitis B Research Network. Evaluating Noninvasive Markers to Identify Advanced Fibrosis by Liver Biopsy in HBV/HIV Co-infected Adults. Hepatology. 2020 Feb;71(2):411-421. doi: 10.1002/hep.30825. Epub 2019 Aug 19.
PMID: 31220357DERIVED
Related Links
Biospecimen
Serum at baseline and every 6 months for 4 years. Liver biopsy at baseline and year 4
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Sterling, MD, MSc
Virginia Commonwealth University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2013
First Posted
August 16, 2013
Study Start
April 1, 2014
Primary Completion
March 31, 2019
Study Completion
March 31, 2019
Last Updated
May 16, 2023
Record last verified: 2023-05