Adaptability of an Undetectable = Untransmissible Model for HBV
1 other identifier
observational
55
1 country
1
Brief Summary
Persons with chronic hepatitis B (HBV) infection and active viremia are infectious and may transmit virus to others through blood/body fluid exposure. Immune tolerant treatment naive persons with hepatitis B infection express anxiety regarding disclosure of their infection status and significant fear of transmission to their partners leading to social isolation and impact on their personal lives. This study will provide data correlating serum and body fluid viral levels in persons with chronic hepatitis B infection not on therapy and those with viral suppression on long-term anti-retroviral therapy (ART) that may support the concept of "Undetectable=Untransmissible" (U=U) in patients with chronic hepatitis B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
March 6, 2026
March 1, 2026
1.5 years
February 27, 2026
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Individuals with Detectable HBV DNA
Assessed among those who have achieved viral supression.
Up to Month 6
HBV DNA Levels
Assessed among those with detectable HBV DNA.
Up to Month 6
Study Arms (4)
Anti-Viral Therapy
Infected individuals on anti-viral therapy.
No Therapy
Infected individuals who are not receiving anti-viral therapy.
Convalesced
Individuals who have cleared HBV infection.
Healthy Controls
Individuals who are uninfected.
Eligibility Criteria
Persons with chronic hepatitis B infection and active viremia
You may qualify if:
- Infected Individuals
- Individuals above 18 years and less than 65 years with chronic hepatitis B infection
- Included according to undermentioned three arms:
- Infected, On-treatment arm: subjects being treated with TAF/TDF for a minimum of 2 years with sustained viral suppression indicating adherence to therapy
- Infected, Untreated control arm: Immune tolerant subjects; 15 with high viral load (\>10\^6) and 5 with low viral load (\<10\^6)
- Uninfected Assay Validation controls: 10 subjects with history of prior infection who have convalesced i.e., have lost surface antigen, and developed surface antibody with viral eradication
- Able and willing to provide informed consent
- Healthy Controls
- Individuals above 18 years and less than 65 years who have never been infected and have been vaccinated
- Able and willing to provide informed consent
You may not qualify if:
- Individuals less than 18 years or greater than 65 years of age
- Prior surgery to genitourinary tract, including prior vasectomy
- Prior interferon therapy
- HIV co-infection
- Hepatitis C virus co-infection
- Hepatitis delta virus co-infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Gilead Sciencescollaborator
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AnnMarie Liapakis, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 4, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to AnnMarie.Liapakis@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: AnnMarie.Liapakis@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.