Adaptability of an Undetectable = Untransmissible Model for Hepatitis B
Official title: Adaptability of an Undetectable = Untransmissible Model for HBV: Are Suppressed Viral Levels in the Serum Consistent Across Body Fluid Reservoirs?
Run by NYU Langone Health · NCT07449091 · Data updated 2026-11-12
This study tests whether very low or undetectable HBV levels in people with chronic hepatitis B mean they are unlikely to transmit the virus to others.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT07449091 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 64 with chronic hepatitis B infection, including treated with long-term viral suppression, untreated immune-tolerant individuals with defined viral loads, and uninfected controls with resolved infection.
✕Probably not a fit
Adults outside the age range, without documented chronic HBV infection, or those not meeting any study arm criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares serum and body fluid HBV levels across three groups: treated individuals with sustained viral suppression, untreated immune-tolerant individuals with high or low viral load, and uninfected controls who have cleared infection markers. It aims to explore the U=U concept in chronic hepatitis B by correlating viral measures with transmissibility. Participants are adults aged 18 to 64, with specific inclusion and exclusion criteria, and will be enrolled at NYU Langone Health with collaboration from Gilead Sciences. The investigation will use cross-sectional data to examine whether low or undetectable HBV viremia corresponds to reduced potential for transmission. Safety and ethical considerations include informed consent and standard clinical monitoring as part of observational research.
Why it matters
Potential benefit: If successful, the findings could inform counseling and public health messaging about HBV transmission risk.
How similar studies have gone: Prior research has explored transmission risk with varying HBV viral loads, but this observational approach to U=U in HBV is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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
Where it's running
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NYU Langone Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: AnnMarie Liapakis, MD — NYU Langone Health
- Study coordinator: AnnMarie Liapakis, MD
- Email: AnnMarie.Liapakis@nyulangone.org
- Phone: 212-263-3751
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.