Comparing Hepatitis B Virus Levels in Blood and Other Body Fluids
Compares hepatitis B virus levels in blood and body fluids in adults with chronic infection.
Plain-language title generated from the registry record
Registry title: Adaptability of an Undetectable = Untransmissible Model for HBV
Key facts
- Where
- New York, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07449091, who can take part
Where in United States
- NYU Langone HealthNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NYU Langone Health
- Trial code
- NCT07449091
- Record updated
- 15 May 2026
- Original description
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.Read full original descriptionShow less
Adaptability of an Undetectable = Untransmissible Model for HBV: Are Suppressed Viral Levels in the Serum Consistent Across Body Fluid Reservoirs?
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.
Inclusion: 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: Prior surgery to genitourinary tract, including prior vasectomy; Prior interferon therapy; HIV co-infection; Hepatitis C virus co-infection; Hepatitis delta virus co-infection; Individuals less than 18 years or greater than 65 years of age.